Recalls / Class III
Class IIID-0306-2026
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.
- Brand name
- Doxazosin Mesylate
- Generic name
- Doxazosin Mesylate
- Active ingredient
- Doxazosin Mesylate
- Route
- Oral
- NDCs
- 29300-351, 29300-352, 29300-353, 29300-354
- FDA application
- ANDA212329
- Affected lot / code info
- Lot # GDSH25006, Exp Date: 08/2027
Why it was recalled
Tablets/Capsules Imprinted with Wrong ID
Recalling firm
- Firm
- Unichem Pharmaceuticals USA Inc.
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 2200, N/A, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- 60,000 tablets
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2026-01-21
- FDA classified
- 2026-02-11
- Posted by FDA
- 2026-02-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0306-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.