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

busPIRone Hydrochloride Tablets

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 24, 2026 at 12:00 AM UTC.

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