FDAHealthApril 13, 2026
Unichem Pharmaceuticals USA Inc. — busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India M
⚠️ Subpotent drug
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 13, 2026
USA Nationwide
What's affected?
- 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.
- UPC
- 0329300246018
- Lot code
- ZBUL25001
Additional details
Lot: ZBUL25001, Exp 12/31/2027
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 10,875 Bottles.
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