April 2026 FDA Recall Buspirone Hydrochloride by Unichem Pharmaceuticals Usa Inc.
D-0511-2026 - Subpotent drug
This Class III drug recall was voluntarily initiated by Unichem Pharmaceuticals Usa Inc. on April 13, 2026 for the product Buspirone Hydrochloride. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0511-2026
Subpotent drug
04-13-2026
05-13-2026
10,875 Bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Unichem Pharmaceuticals USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# Lot: ZBUL25001, Exp 12/31/2027
