Unichem Pharmaceuticals USA Inc. recalls busPIRone Hydrochloride Tablets
- Recalling company
- Unichem Pharmaceuticals USA Inc.
- Product
- 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
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Apr 13, 2026
- Reported
- May 13, 2026
- Distribution
- USA Nationwide
- Status
- Ongoing
- Quantity
- 10,875 Bottles
- Lot / codes
- Lot: ZBUL25001, Exp 12/31/2027
- Company location
- East Brunswick, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0511-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0511-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.