Moderate riskFDA DrugClass III

Unichem doxazosin 4 mg tablets recalled for wrong imprint

Unichem Pharmaceuticals distributed 60,000 tablets of Doxazosin 4 mg with incorrect imprinting on the tablets themselves. This labeling error could cause confusion about the medication's identity and strength. The affected lot is GDSH25006, which expires in August 2027.

From the FDA notice · Read the official notice ↗

What to do

  1. Check your Doxazosin bottle for lot number GDSH25006.
  2. If you have this lot, contact your pharmacist or doctor before taking any more doses.
  3. Do not use tablets from this lot without speaking to your healthcare provider first.
  4. Return the bottle to your pharmacy for safe disposal or replacement.

Is yours affected?

Compare your label or packaging with the recalled product.

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.
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
60,000 tablets
Illnesses reported
None reported
Manufactured in
1 Tower Center Blvd Ste 2200, N/A, East Brunswick, NJ, United States
Classification
Class III
Recall number
D-0306-2026

In the FDA's words

Description
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. Tablets/Capsules Imprinted with Wrong ID Lot # GDSH25006, Exp Date: 08/2027 Distribution: Nationwide Affected quantity: 60,000 tablets
Hazard
Tablets/Capsules Imprinted with Wrong ID

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