January 2026 FDA Recall Doxazosin Mesylate by Unichem Pharmaceuticals Usa Inc.
D-0306-2026 - Tablets/Capsules Imprinted with Wrong ID
This Class III drug recall was voluntarily initiated by Unichem Pharmaceuticals Usa Inc. on January 21, 2026 for the product Doxazosin Mesylate. The FDA reported the reason for recall as tablets/capsules imprinted with wrong id. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0306-2026
Tablets/Capsules Imprinted with Wrong ID
01-21-2026
02-18-2026
60,000 tablets
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.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10.
Batch or Lot Expiration Information
Lot# GDSH25006, Exp Date: 08/2027
