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Drug FDA Class III Ongoing Mislabeling

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

Unichem Pharmaceuticals USA Inc. Published Feb 18, 2026

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Unichem Pharmaceuticals USA Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Tablets/Capsules Imprinted with Wrong ID

Affected products (1)

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.

DOXAZOSIN MESYLATE · 60,000 tablets

NDC: 29300-351, 29300-352, 29300-353, 29300-354, 29300-351-13, 29300-351-01, 29300-351-10, 29300-352-13, 29300-352-01, 29300-352-10, 29300-353-13, 29300-353-01, 29300-353-10, 29300-354-13, 29300-354-01, 29300-354-10
Lot codes: GDSH25006
Code info: Lot # GDSH25006, Exp Date: 08/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Jan 21, 2026
  2. Published
    Feb 18, 2026
Recall number
D-0306-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.