busPIRone Hydrochloride Tablets recall (Unichem Pharmaceuticals USA Inc.)
DrugClass IIIOngoing
Summary: Unichem Pharmaceuticals USA Inc. is recalling 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.. Reason: Subpotent drug.
What is being recalled
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.
Why
Subpotent drug
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
USA Nationwide
How to tell if yours is affected
Lot: ZBUL25001, Exp 12/31/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0511-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | April 13, 2026 |
| Reported | May 13, 2026 |
| Company | Unichem Pharmaceuticals USA Inc. |
| Company location | East Brunswick, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 10,875 Bottles |
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