FDA Recall D-0306-2026

Unichem Pharmaceuticals USA Inc. · East Brunswick, NJ

Class III Ongoing 113 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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.

Lot / code: Lot # GDSH25006, Exp Date: 08/2027

Quantity: 60,000 tablets

Reason for recall

Tablets/Capsules Imprinted with Wrong ID

Recall record

Recall number: D-0306-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2026-01-21
Classified by FDA Center: 2026-02-11
FDA published: 2026-02-18
Recalling firm: Unichem Pharmaceuticals USA Inc.
Firm location: East Brunswick, NJ

Drug identification

Brand name(s): DOXAZOSIN MESYLATE
Generic name(s): DOXAZOSIN MESYLATE
Manufacturer(s): Unichem Pharmaceuticals (USA), Inc.
NDC(s): 29300-351, 29300-352, 29300-353, 29300-354
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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