← FDA ENFORCEMENT
D-0511-2026Class III

Unichem Pharmaceuticals USA Inc.

Recalling firm
Unichem Pharmaceuticals USA Inc.
Product type
Drug
Status
Ongoing
Report date
2026-05-13
Distribution
USA Nationwide
Firm state
NJ
Product quantity
10,875 Bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Subpotent drug

Product description

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.

Code / lot info

Lot: ZBUL25001, Exp 12/31/2027

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.