FDANot Yet Classified · Drug · FDA event 99837; recall number pending · Recalled September 16, 2026

fentaNYL Citrate recall — OurPharma LLC

Agency report date: September 16, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: fentaNYL Citrate
Company / brand: OurPharma
Lot / serial / date codes: Lot #: 101301260605, BUD: 12/9/2026.
Distribution: Nationwide within the U.S

Agency product description and boundaries

fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Affected product: fentaNYL Citrate recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Not yet assigned by the FDA — identified by FDA event ID 99837
Brand: All OurPharma recalls
Classification: Not Yet Classified
Units affected: 1,610 bags
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

fentaNYL Citrate recall status

Companies & origin

Recalling firm location: Fayetteville, AR, United States
Firm address: 2512 S City Lake Rd, 72701-5013

Identifying details (verbatim from the notice)

Product codes / lots: Lot #: 101301260605, BUD: 12/9/2026.
Distribution: Nationwide within the U.S
Firm notified the public via: Letter
FDA event ID: 99837
Recall initiated: September 3, 2026
FDA report date: September 16, 2026

Other drug recalls from around the same time

Thyroid Tablets recall — VITRUVIAS THERAPEUTICS INCFDA · September 23, 2026
0 recall — B BRAUN MEDICAL INCFDA · September 16, 2026
Epinephrine Injection recall — American Regent, Inc.FDA · September 16, 2026
Dextrose Injection recall — Baxter Healthcare CorporationFDA · September 16, 2026
Glutathione 200 mg/mL recall — OPTIMAL BALANCE PHARMACYFDA · September 9, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved September 29, 2026 at 12:00 AM UTC.

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