281 recent drug recalls in our current data. Showing the 200 most recent.
Presence of Particulate Matter
Company / brand: Baxter Healthcare
Affected product: Cefazolin in Dextrose
Official ID EVT-99463-1krekt6 · Official record ↗
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Company / brand: Liebel-Flarsheim Company
Affected product: Optiray Imaging Bulk Package-350
Official ID D-0773-2026 · Official record ↗
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Company / brand: Victory Medical Center Pharmacy
Affected product: Glutathione (MDV)
Official ID D-0772-2026 · Official record ↗
Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Company / brand: Buy-Herbal
Affected product: Kian Pee Wan Capsules
Official ID D-0769-2026 · Official record ↗
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Company / brand: Heritage Pharmaceuticals
Affected product: CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION
Official ID D-0768-2026 · Official record ↗
Lack of assurance of sterility. The recall is due to potential contamination
Company / brand: Prestige Brands Holdings
Affected product: CLEAR EYES Maximum Itchy Eye Relief
Official ID D-0766-2026 · Official record ↗
CGMP Deviations:Noted during FDA inspection
Company / brand: Shoolin Pharma Chem LLP
Affected product: SILDENAFIL CITRATE USP
Official ID D-0763-2026 · Official record ↗
CGMP Deviations:Noted during FDA inspection
Company / brand: Shoolin Pharma Chem LLP
Affected product: TADALAFIL USP
Official ID D-0762-2026 · Official record ↗
CGMP Deviations:Noted during FDA inspection
Company / brand: Shoolin Pharma Chem LLP
Affected product: TADALAFIL USP
Official ID D-0761-2026 · Official record ↗
CGMP Deviations:Noted during FDA inspection
Company / brand: Shoolin Pharma Chem LLP
Affected product: TADALAFIL USP
Official ID D-0760-2026 · Official record ↗
CGMP Deviations:Noted during FDA inspection
Company / brand: Shoolin Pharma Chem LLP
Affected product: SILDENAFIL CITRATE USP
Official ID D-0759-2026 · Official record ↗
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care
Affected product: SEMAGLUTIDE 20mg (5mg/mL)
Official ID D-0757-2026 · Official record ↗
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care
Affected product: SEMAGLUTIDE 10mg (5mg/mL)
Official ID D-0756-2026 · Official record ↗
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care
Affected product: SEMAGLUTIDE 7
Official ID D-0755-2026 · Official record ↗
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care
Affected product: SEMAGLUTIDE 5mg (1mg/mL)
Official ID D-0754-2026 · Official record ↗
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care
Affected product: SEMAGLUTIDE 2
Official ID D-0753-2026 · Official record ↗
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care
Affected product: SEMAGLUTIDE 0
Official ID D-0752-2026 · Official record ↗
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care
Affected product: SEMAGLUTIDE 9mg (4
Official ID D-0751-2026 · Official record ↗
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care
Affected product: SEMAGLUTIDE 4
Official ID D-0750-2026 · Official record ↗
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care
Affected product: SEMAGLUTIDE 6
Official ID D-0749-2026 · Official record ↗
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care
Affected product: SEMAGLUTIDE 2
Official ID D-0748-2026 · Official record ↗
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care
Affected product: SEMAGLUTIDE 12
Official ID D-0747-2026 · Official record ↗
Failed Dissolution Specifications
Company / brand: Novartis Pharmaceuticals
Affected product: Diovan (valsartan) 160 mg
Official ID D-0746-2026 · Official record ↗
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Company / brand: Zydus Pharmaceuticals (USA)
Affected product: Mirabegron Extended-Release Tablets
Official ID D-0745-2026 · Official record ↗
Presence of Particulate Matter; identified as stainless steel
Company / brand: Sunny Pharmtech
Affected product: Cyclophosphamide for Injection
Official ID D-0744-2026 · Official record ↗
Presence of Particulate Matter; identified as stainless steel
Company / brand: Sunny Pharmtech
Affected product: Cyclophosphamide for Injection
Official ID D-0743-2026 · Official record ↗
Incorrect Product Formulation
Company / brand: Central Admixture Pharmacy Services
Affected product: Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Official ID D-0740-2026 · Official record ↗
shortfill; reports of empty capsules.
Company / brand: Aurobindo Pharma USA
Affected product: Dicyclomine Hydrochloride Capsules
Official ID D-0733-2026 · Official record ↗
Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test analysis w.r.t Impurity II, Impur…
Company / brand: Ascend Laboratories
Affected product: Dabigatran Etexilate Capsules
Official ID EVT-99421-191x326 · Official record ↗
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Company / brand: Ascend Laboratories
Affected product: Dabigatran Etexilate Capsules
Official ID D-0739-2026 · Official record ↗
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Company / brand: Ascend Laboratories
Affected product: Dabigatran Etexilate Capsules
Official ID D-0738-2026 · Official record ↗
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Company / brand: Ascend Laboratories
Affected product: Dabigatran Etexilate Capsules
Official ID D-0737-2026 · Official record ↗
Presence of precipitate
Company / brand: MYLAN PHARMACEUTICALS
Affected product: Mycophenolate Mofetil for Injection USP
Official ID D-0734-2026 · Official record ↗
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Company / brand: Glenmark Pharmaceuticals
Affected product: Azelaic Acid Gel
Official ID D-0731-2026 · Official record ↗
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Company / brand: MICRO LABS USA
Affected product: Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Official ID D-0730-2026 · Official record ↗
Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.
Company / brand: Precision Dose
Affected product: Glycopyrrolate Oral Solution
Official ID EVT-99388-g6s9bf · Official record ↗
Failed Dissolution Specifications
Company / brand: Supernus Pharmaceuticals
Affected product: Trokendi XR
Official ID EVT-99375-1qlo6cy · Official record ↗
Failed Dissolution Specifications
Company / brand: Supernus Pharmaceuticals
Affected product: Trokendi XR
Official ID D-0758-2026 · Official record ↗
Presence of Foreign Tablets/Capsules
Company / brand: Bionpharma
Affected product: Divalproex Sodium Delayed-Release Tablets
Official ID D-0742-2026 · Official record ↗
Failed Impurities/Degradation Specifications
Company / brand: Precision Dose
Affected product: Glycopyrrolate Oral Solution
Official ID D-0741-2026 · Official record ↗
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testin…
Company / brand: Ascend Laboratories
Affected product: Dabigatran etexilate Capsules
Official ID D-0736-2026 · Official record ↗
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testin…
Company / brand: Ascend Laboratories
Affected product: Dabigatran etexilate Capsules
Official ID D-0735-2026 · Official record ↗
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to …
Company / brand: JB Chemicals and Pharmaceuticals
Affected product: Cetirizine Hydrochloride Tablets USP 5 mg
Official ID D-0732-2026 · Official record ↗
Presence of Particulate Matter: Hair was found in products
Company / brand: Fresenius Kabi USA
Affected product: Xylocaine (lidocaine HCl Injection
Official ID D-0729-2026 · Official record ↗
Presence of Particulate Matter: Hair was found in products
Company / brand: Fresenius Kabi USA
Affected product: Xylocaine (lidocaine HCl Injection
Official ID D-0728-2026 · Official record ↗
Presence of Particulate Matter: Hair was found in products
Company / brand: Fresenius Kabi USA
Affected product: Naropin (ropivacaine hydrochloride Injection
Official ID D-0727-2026 · Official record ↗
Presence of Particulate Matter: Hair was found in products
Company / brand: Fresenius Kabi USA
Affected product: Lidocaine HCl Injection
Official ID D-0726-2026 · Official record ↗
Presence of Particulate Matter: Hair was found in product
Company / brand: Fresenius Kabi USA
Affected product: Glycopyrrolate Injection
Official ID D-0725-2026 · Official record ↗
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Company / brand: Rising Pharma Holding
Affected product: Rising
Official ID D-0724-2026 · Official record ↗
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co
Affected product: Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0
Official ID D-0722-2026 · Official record ↗
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co
Affected product: Rohto Cooling Eye Drops Dry Aid (povidone 0
Official ID D-0721-2026 · Official record ↗
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co
Affected product: Rohto Cooling Eye Drops Dry Aid (povidone 0
Official ID D-0720-2026 · Official record ↗
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co
Affected product: Rohto Cooling Eye Drops Digi Eye (hypromellose 0
Official ID D-0719-2026 · Official record ↗
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co
Affected product: Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0
Official ID D-0718-2026 · Official record ↗
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co
Affected product: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0
Official ID D-0717-2026 · Official record ↗
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co
Affected product: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0
Official ID D-0716-2026 · Official record ↗
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co
Affected product: Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0
Official ID D-0715-2026 · Official record ↗
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Company / brand: Asclemed USA
Affected product: Lidolog Kit
Official ID D-0713-2026 · Official record ↗
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Company / brand: Ascend Laboratories
Affected product: Amlodipine and Olmesartan Medoxomil Tablets
Official ID D-0712-2026 · Official record ↗
Subpotent Drug
Company / brand: Major Pharmaceuticals
Affected product: Levothyroxine Sodium Tablets
Official ID D-0711-2026 · Official record ↗
Subpotent Drug
Company / brand: Major Pharmaceuticals
Affected product: Levothyroxine Sodium Tablets
Official ID D-0710-2026 · Official record ↗
Subpotent Drug
Company / brand: Major Pharmaceuticals
Affected product: Levothyroxine Sodium Tablets
Official ID D-0709-2026 · Official record ↗
Subpotent Drug
Company / brand: Major Pharmaceuticals
Affected product: Levothyroxine Sodium Tablets
Official ID D-0708-2026 · Official record ↗
Subpotent Drug
Company / brand: Major Pharmaceuticals
Affected product: Levothyroxine Sodium Tablets
Official ID D-0707-2026 · Official record ↗
Subpotent Drug
Company / brand: Major Pharmaceuticals
Affected product: Levothyroxine Sodium Tablets
Official ID D-0706-2026 · Official record ↗
Subpotent Drug
Company / brand: Major Pharmaceuticals
Affected product: Levothyroxine Sodium Tablets
Official ID D-0705-2026 · Official record ↗
Subpotent Drug
Company / brand: Major Pharmaceuticals
Affected product: Levothyroxine Sodium Tablets
Official ID D-0704-2026 · Official record ↗
Subpotent Drug
Company / brand: Major Pharmaceuticals
Affected product: Levothyroxine Sodium Tablets
Official ID D-0703-2026 · Official record ↗
Subpotent Drug
Company / brand: Major Pharmaceuticals
Affected product: Levothyroxine Sodium Tablets
Official ID D-0702-2026 · Official record ↗
Subpotent Drug
Company / brand: Major Pharmaceuticals
Affected product: Levothyroxine Sodium Tablets
Official ID D-0701-2026 · Official record ↗
Subpotent Drug
Company / brand: Major Pharmaceuticals
Affected product: Levothyroxine Sodium Tablets
Official ID D-0700-2026 · Official record ↗
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Company / brand: CareFusion 213
Affected product: BD ChloraPrep Clear
Official ID D-0690-2026 · Official record ↗
Lack of Assurance of Sterility
Company / brand: Chiesi USA
Affected product: CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0
Official ID D-0689-2026 · Official record ↗
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Company / brand: Bell Pharmaceuticals
Affected product: CAREone
Official ID D-0688-2026 · Official record ↗
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Company / brand: Bell Pharmaceuticals
Affected product: meijer
Official ID D-0687-2026 · Official record ↗
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Company / brand: Bell Pharmaceuticals
Affected product: Foster & Thrive
Official ID D-0686-2026 · Official record ↗
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Company / brand: Bell Pharmaceuticals
Affected product: LEADER
Official ID D-0685-2026 · Official record ↗
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Company / brand: Bell Pharmaceuticals
Affected product: GOOD NEIGHBOR PHARMACY
Official ID D-0684-2026 · Official record ↗
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Company / brand: Bell Pharmaceuticals
Affected product: FAMILY Wellness
Official ID D-0683-2026 · Official record ↗
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Company / brand: Bell Pharmaceuticals
Affected product: AUDIOLOGIST'S CHOICE
Official ID D-0682-2026 · Official record ↗
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Company / brand: Bell Pharmaceuticals
Affected product: TopCare Health
Official ID D-0681-2026 · Official record ↗
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Company / brand: Bell Pharmaceuticals
Affected product: QC Quality Choice
Official ID D-0680-2026 · Official record ↗
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Company / brand: Bell Pharmaceuticals
Affected product: Clinere
Official ID D-0679-2026 · Official record ↗
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Company / brand: Bell Pharmaceuticals
Affected product: CVS Health
Official ID D-0678-2026 · Official record ↗
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Company / brand: Padagis US
Affected product: Nystatin Cream USP
Official ID D-0677-2026 · Official record ↗
cGMP deviations
Company / brand: Shimoga Chemicals
Affected product: Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS
Official ID D-0691-2026 · Official record ↗
Lack of Sterility Assurance
Company / brand: Reliance Life Sciences Private
Affected product: Azacitidine for Injection 100mg/Vial
Official ID D-0674-2026 · Official record ↗
Lack of Sterility Assurance
Company / brand: Reliance Life Sciences Private
Affected product: Bortezomib for Injection 3
Official ID D-0673-2026 · Official record ↗
Lack of Sterility Assurance
Company / brand: Reliance Life Sciences Private
Affected product: Pemetrexed for Injection 500mg/Vial
Official ID D-0672-2026 · Official record ↗
Lack of Sterility Assurance
Company / brand: Reliance Life Sciences Private
Affected product: Pemetrexed for Injection 100mg/Vial
Official ID D-0671-2026 · Official record ↗
Subpotent drug
Company / brand: Gasco Industrial
Affected product: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Official ID D-0670-2026 · Official record ↗
Subpotent drug
Company / brand: Gasco Industrial
Affected product: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Official ID D-0669-2026 · Official record ↗
Subpotent drug
Company / brand: Gasco Industrial
Affected product: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Official ID D-0668-2026 · Official record ↗
Subpotent drug
Company / brand: Gasco Industrial
Affected product: Gasco Isopropyl Alcohol 70%
Official ID D-0667-2026 · Official record ↗
Subpotent drug
Company / brand: Gasco Industrial
Affected product: Gasco Isopropyl Alcohol 70%
Official ID D-0666-2026 · Official record ↗
Subpotent drug
Company / brand: Gasco Industrial
Affected product: Gasco Isopropyl Alcohol 70%
Official ID D-0665-2026 · Official record ↗
Failed Impurities/Degradation Specifications
Company / brand: QuVa Pharma
Affected product: Methohexital Sodium
Official ID D-0664-2026 · Official record ↗
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Company / brand: BioMed Laboratories
Affected product: Medline Remedy Specialized Silicone Cream (Hydraguard-D )
Official ID D-0663-2026 · Official record ↗
Failed Impurities/Degradation Specifications
Company / brand: ONESOURCE SPECIALTY PHARMA
Affected product: Methohexital Sodium for Injection
Official ID D-0662-2026 · Official record ↗
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Company / brand: Lupin Pharmaceuticals
Affected product: Glucagon Emergency Kit for Low Blood Sugar
Official ID EVT-99296-c9qbin · Official record ↗
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Company / brand: Lupin Pharmaceuticals
Affected product: Glucagon Emergency Kit for Low Blood Sugar
Official ID D-0723-2026 · Official record ↗
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Company / brand: McKesson
Affected product: Gemcitabine Injection
Official ID D-0714-2026 · Official record ↗
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Company / brand: Blaine Labs
Affected product: Revitaderm Wound Care
Official ID D-0699-2026 · Official record ↗
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Company / brand: Blaine Labs
Affected product: Fungal Fusion ERADICATION Solution
Official ID D-0698-2026 · Official record ↗
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Company / brand: Blaine Labs
Affected product: TERPENICOL Antifungal Solution
Official ID D-0697-2026 · Official record ↗
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Company / brand: Blaine Labs
Affected product: vite20 Antifungal Cream
Official ID D-0696-2026 · Official record ↗
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Company / brand: Blaine Labs
Affected product: TERPENICOL Antifungal Cream (Undecylenic Acid 13%)
Official ID D-0695-2026 · Official record ↗
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Company / brand: Blaine Labs
Affected product: TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%)
Official ID D-0694-2026 · Official record ↗
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Company / brand: Blaine Labs
Affected product: TRIFLUENT PHARMA TRIDERGEL Wound Care Gel
Official ID D-0693-2026 · Official record ↗
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Company / brand: Blaine Labs
Affected product: Revitaderm Wound Care Gel
Official ID D-0692-2026 · Official record ↗
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Company / brand: Cipla USA
Affected product: Cinacalcet Hydrochloride Tablets
Official ID D-0676-2026 · Official record ↗
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Company / brand: Cipla USA
Affected product: Cinacalcet Hydrochloride Tablets
Official ID D-0675-2026 · Official record ↗
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Company / brand: Cipla USA
Affected product: Cinacalcet Hydrochloride Tablets
Official ID D-0661-2026 · Official record ↗
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Company / brand: Lannett Company
Affected product: Dextroamphetamine Saccharate
Official ID D-0660-2026 · Official record ↗
Lack of Assurance of Sterility
Company / brand: Asclemed USA
Affected product: Lidocaine HCl Injection USP
Official ID D-0659-2026 · Official record ↗
Lack of Assurance of Sterility
Company / brand: Asclemed USA
Affected product: Accucaine
Official ID D-0658-2026 · Official record ↗
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Company / brand: Boehringer Ingelheim Pharmaceuticals
Affected product: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets)
Official ID D-0657-2026 · Official record ↗
Subpotent Drug
Company / brand: ACCORD HEALTHCARE
Affected product: Levothyroxine Sodium Tablets
Official ID D-0656-2026 · Official record ↗
Presence of Foreign Substance
Company / brand: Lupin Pharmaceuticals
Affected product: prednisoLONE Acetate Ophthalmic Suspension
Official ID D-0655-2026 · Official record ↗
Failed Impurities/Degradation Specifications
Company / brand: SUN PHARMACEUTICAL INDUSTRIES
Affected product: Fexofenadine Hydrochloride Tablets
Official ID D-0654-2026 · Official record ↗
Lack of assurance of Sterility:
Company / brand: ACCORD BIOPHARMA
Affected product: IMULDOSA
Official ID D-0653-2026 · Official record ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Company / brand: CareFusion 213
Affected product: BD ChloraPrep CLear
Official ID D-0652-2026 · Official record ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Company / brand: CareFusion 213
Affected product: BD ChloraPrep CLear
Official ID D-0651-2026 · Official record ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Company / brand: CareFusion 213
Affected product: BD ChloraPrep Scrub Teal
Official ID D-0650-2026 · Official record ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Company / brand: CareFusion 213
Affected product: BD ChloraPrep Scrub Teal
Official ID D-0649-2026 · Official record ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Company / brand: CareFusion 213
Affected product: BD ChloraPrep Hi-Lite Orange
Official ID D-0648-2026 · Official record ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Company / brand: CareFusion 213
Affected product: BD ChloraPrep Hi-Lite Orange
Official ID D-0647-2026 · Official record ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Company / brand: CareFusion 213
Affected product: ChloraPrep FREPP
Official ID D-0646-2026 · Official record ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Company / brand: CareFusion 213
Affected product: BD ChloraPrep Clear
Official ID D-0645-2026 · Official record ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Company / brand: CareFusion 213
Affected product: BD PurPrep
Official ID D-0644-2026 · Official record ↗
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Company / brand: CareFusion 213
Affected product: BD ChloraPrep Hi-Lite Orange
Official ID D-0643-2026 · Official record ↗
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Company / brand: SUN PHARMACEUTICAL INDUSTRIES
Affected product: Perampanel CIII Tablets
Official ID D-0628-2026 · Official record ↗
sub potency
Company / brand: Elevate Oral Care
Affected product: Povi-One
Official ID D-0627-2026 · Official record ↗
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Company / brand: Annora Pharma Private
Affected product: Lacosamide Tablets
Official ID D-0626-2026 · Official record ↗
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Company / brand: CareFusion 213
Affected product: BD ChloraPrep FREPP Clear
Official ID D-0625-2026 · Official record ↗
Non-Sterility: Due to presence of Aspergillus penicillioides.
Company / brand: CareFusion 213
Affected product: BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (I
Official ID D-0624-2026 · Official record ↗
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Company / brand: CareFusion 213
Affected product: BD ChloraPrep FREPP Clear
Official ID D-0623-2026 · Official record ↗
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Company / brand: CareFusion 213
Affected product: BD ChloraPrep Clear
Official ID D-0622-2026 · Official record ↗
Lack of Assurance of Sterility
Company / brand: PReye
Affected product: PReye Vitamin See Antioxidant Preservative Free Eye Drops
Official ID D-0621-2026 · Official record ↗
Presence of foreign substance
Company / brand: ANI Pharmaceuticals
Affected product: hydrOXYzine Hydrochloride Oral Solution
Official ID D-0619-2026 · Official record ↗
Incorrect product formulation: bag did not contain copper and famotidine per label.
Company / brand: Central Admixture Pharmacy Services
Affected product: Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Official ID D-0618-2026 · Official record ↗
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Company / brand: Direct Rx
Affected product: DULOXETINE D/R
Official ID D-0617-2026 · Official record ↗
CGMP Deviations
Company / brand: Amgen
Affected product: Sensipar (cinacalcet) Tablets
Official ID D-0616-2026 · Official record ↗
Presence of Foreign Substance.
Company / brand: Amgen
Affected product: Corlanor (ivabradine) tablets
Official ID D-0615-2026 · Official record ↗
CGMP Deviations
Company / brand: Amgen
Affected product: Sensipar (cinacalcet) Tablets
Official ID D-0614-2026 · Official record ↗
CGMP Deviations
Company / brand: Amgen
Affected product: Sensipar (cinacalcet) Tablets
Official ID D-0613-2026 · Official record ↗
Presence of Foreign Substance.
Company / brand: Amgen
Affected product: Corlanor (ivabradine) tablets
Official ID D-0612-2026 · Official record ↗
CGMP Deviations
Company / brand: Ajanta Pharma USA
Affected product: Fenofibrate Capsules
Official ID D-0611-2026 · Official record ↗
Subpotent Drug
Company / brand: The Harvard Drug Group
Affected product: Carton Label
Official ID D-0609-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Med Pride
Official ID D-0642-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Med Pride
Official ID D-0641-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Med Pride
Official ID D-0640-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Med Pride
Official ID D-0639-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Med Pride
Official ID D-0638-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Med Pride
Official ID D-0637-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Med Pride
Official ID D-0636-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Med Pride
Official ID D-0635-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Cura Hongos
Official ID D-0634-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Rapidol
Official ID D-0633-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Lil Drug Store
Official ID D-0632-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Circle K
Official ID D-0631-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Lucky Super Soft
Official ID D-0630-2026 · Official record ↗
CGMP Deviations; deficiencies observed during FDA inspection
Company / brand: Dabur India
Affected product: Lucky Super Soft
Official ID D-0629-2026 · Official record ↗
Failed Dissolution Specifications
Company / brand: Inventia Healthcare
Affected product: Chlorthalidone Tablets
Official ID D-0610-2026 · Official record ↗
Labeling: Incorrect or Missing Lot and/or Exp Date
Company / brand: Sandoz
Affected product: Focalin XR (dexmethylphenidate HCl) 5 mg
Official ID D-0608-2026 · Official record ↗
Defective container:may contain bottles with incomplete seals
Company / brand: Keystone Industries
Affected product: safco SensiCaine-Ultra (20% Benzocaine)
Official ID D-0606-2026 · Official record ↗
Defective container:may contain bottles with incomplete seals
Company / brand: Keystone Industries
Affected product: PureLife
Official ID D-0605-2026 · Official record ↗
Defective container:may contain bottles with incomplete seals
Company / brand: Keystone Industries
Affected product: Dental City TOPICAL ANESTHETIC GEL
Official ID D-0604-2026 · Official record ↗
Defective container:may contain bottles with incomplete seals
Company / brand: Keystone Industries
Affected product: Burkhart topical anesthetic gel
Official ID D-0603-2026 · Official record ↗
Defective container:may contain bottles with incomplete seals
Company / brand: Keystone Industries
Affected product: DHP Topical Anesthetic Gel
Official ID D-0602-2026 · Official record ↗
Defective container:may contain bottles with incomplete seals
Company / brand: Keystone Industries
Affected product: Quala Dental Products
Official ID D-0601-2026 · Official record ↗
Defective container:may contain bottles with incomplete seals
Company / brand: Keystone Industries
Affected product: Pearson Quality Topical Anesthetic Gel (20% Benzocaine)
Official ID D-0600-2026 · Official record ↗
Crystallization; identified as Buprenorphine free base
Company / brand: Par Health USA
Affected product: Buprenorphine HCl
Official ID D-0596-2026 · Official record ↗
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Company / brand: Ajanta Pharma USA
Affected product: Aripiprazole Tablets USP
Official ID D-0594-2026 · Official record ↗
Subpotent Drug
Company / brand: IntegraDose Compounding Services
Affected product: Vasopressin 2 Units/2 mL in 0
Official ID D-0593-2026 · Official record ↗
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Company / brand: PAI Holdings
Affected product: VistaPharm
Official ID D-0592-2026 · Official record ↗
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Company / brand: PAI Holdings
Affected product: VistaPharm
Official ID D-0591-2026 · Official record ↗
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Company / brand: PAI Holdings
Affected product: VistaPharm
Official ID D-0590-2026 · Official record ↗
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Company / brand: PAI Holdings
Affected product: VistaPharm
Official ID D-0589-2026 · Official record ↗
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Company / brand: Glenmark Pharmaceuticals
Affected product: Alyacen 7/7/7
Official ID D-0588-2026 · Official record ↗
Microbial Contamination of Non-Sterile Products
Company / brand: BEEKEEPER'S NATURALS USA
Affected product: BEEKEEPER'S NATURALS Saline Nasal Spray
Official ID D-0620-2026 · Official record ↗
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Company / brand: SUN PHARMACEUTICAL INDUSTRIES
Affected product: Budesonide Inhalation Suspension
Official ID D-0607-2026 · Official record ↗
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Company / brand: Ascend Laboratories
Affected product: Minocycline Hydrochloride Extended-Release Tablets
Official ID D-0597-2026 · Official record ↗
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Company / brand: Haleon US Holdings
Affected product: Gas-X Extra Strength
Official ID D-0595-2026 · Official record ↗
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Company / brand: Golden State Medical Supply
Affected product: GSMS Incorporated
Official ID D-0587-2026 · Official record ↗
Microbial contamination of sterile products
Company / brand: Zep
Affected product: Zep
Official ID D-0586-2026 · Official record ↗
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Company / brand: Amneal Pharmaceuticals
Affected product: Primidone Tablets
Official ID D-0585-2026 · Official record ↗
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Company / brand: Breckenridge Pharmaceutical
Affected product: Duloxetine Delayed-Release Capsules
Official ID D-0583-2026 · Official record ↗
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Company / brand: Breckenridge Pharmaceutical
Affected product: Duloxetine Delayed-Release Capsules
Official ID D-0582-2026 · Official record ↗
Failed Impurities/Degradations Specifications
Company / brand: Fresenius Kabi USA
Affected product: Epinephrine Injection
Official ID D-0581-2026 · Official record ↗
Presence of Particulate matter: Particulate matter identified as glass.
Company / brand: SUN PHARMACEUTICAL INDUSTRIES
Affected product: DOXOrubin Hydrochloride Liposome injection
Official ID D-0580-2026 · Official record ↗
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Company / brand: SUN PHARMACEUTICAL INDUSTRIES
Affected product: Xyvona (levorphanol tartrate tablets)
Official ID D-0599-2026 · Official record ↗
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Company / brand: SUN PHARMACEUTICAL INDUSTRIES
Affected product: Xyvona (levorphanol tartrate tablets)
Official ID D-0598-2026 · Official record ↗
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Company / brand: Lannett Company
Affected product: Niacin Extended-release Tablets
Official ID D-0584-2026 · Official record ↗
Presence of foreign substance: small metallic particles in chewable tablets.
Company / brand: Guardian Drug Co
Affected product: TopCare health
Official ID D-0579-2026 · Official record ↗
Presence of foreign substance: small metallic particles in chewable tablets.
Company / brand: Guardian Drug Co
Affected product: TopCare health
Official ID D-0578-2026 · Official record ↗
Presence of foreign substance: small metallic particles in chewable tablets.
Company / brand: Guardian Drug Co
Affected product: EQUALINE ultra strength
Official ID D-0577-2026 · Official record ↗
Presence of foreign substance: small metallic particles in chewable tablets.
Company / brand: Guardian Drug Co
Affected product: EQUALINE extra strength
Official ID D-0576-2026 · Official record ↗
Presence of foreign substance: small metallic particles in chewable tablets.
Company / brand: Guardian Drug Co
Affected product: GOODSENSE Ultra Strength
Official ID D-0575-2026 · Official record ↗
Presence of foreign substance: small metallic particles in chewable tablets.
Company / brand: Guardian Drug Co
Affected product: GOODSENSE Extra Strength
Official ID D-0574-2026 · Official record ↗
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Sources last checked September 7, 2026 at 6:00 AM UTC.