Class IIIOngoing

busPIRone Hydrochloride Tablets recall

FDA recall D-0511-2026 · initiated Apr 13, 2026

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Subpotent drug

Details

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.
Recalling company: Unichem Labs Ltd
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA Nationwide
Initiated: Apr 13, 2026
FDA report date: May 13, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0511-2026 ↗

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