FDA Drugs recall ·
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only… recall
- Recall number
- D-0511-2026
- Date
- (initiated April 13, 2026)
- Company / brand
- Unichem Pharmaceuticals USA Inc.
1 Tower Center Blvd Ste 2200, East Brunswick, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 10,875 Bottles
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Subpotent drug
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: ZBUL25001, Exp 12/31/2027
Distribution
USA Nationwide
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0511-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.