FreshRecalls

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FDAClass III · Drug · Recalled May 13, 2026

busPIRone Hydrochloride Tablets recall — Unichem Pharmaceuticals USA Inc.

Hazard: Subpotent drug

Class III: not likely to cause adverse health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0511-2026
Brand
Unichem Pharmaceuticals USA
Classification
Class III
Units affected
10,875 Bottles
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

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.

Affected products

Companies & origin

Recalling firm location
East Brunswick, NJ, United States
Firm address
1 Tower Center Blvd Ste 2200, 08816-1145

Identifying details (verbatim from the notice)

Product codes / lots
Lot: ZBUL25001, Exp 12/31/2027
Distribution
USA Nationwide
Firm notified the public via
Letter
FDA event ID
98728
Recall initiated
April 13, 2026
FDA classified
May 1, 2026
FDA report date
May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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