FDAClass III · Drug · Recall D-0511-2026 · Recalled May 13, 2026
busPIRone Hydrochloride Tablets recall — Unichem Pharmaceuticals USA Inc.
Agency report date: May 13, 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.
Agency product description and boundaries
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
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: Subpotent drug
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class III: not likely to cause adverse health consequences.
Affected product: busPIRone Hydrochloride Tablets recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
Other drug recalls from around the same time
- BEEKEEPER'S NATURALS Saline Nasal Spray recall — BEEKEEPER'S NATURALS USA INC.FDA · June 17, 2026
- Gas-X Extra Strength recall — Haleon US Holdings LLCFDA · June 17, 2026
- DOXOrubin Hydrochloride Liposome injection recall — SUN PHARMACEUTICAL INDUSTRIES INCFDA · June 17, 2026
- MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%) recall — Wisconsin Pharmacal CompanyFDA · May 27, 2026
- Lactated Ringer's Injection USP recall — B BRAUN MEDICAL INCFDA · May 13, 2026
- 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 ↗
Found something wrong or missing? Report a data error.
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 6:00 PM UTC. Record retrieved August 11, 2026 at 6:00 PM UTC.