Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 To
Summary
The FDA issued a Class III for Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by U by Unichem Pharmaceuticals USA Inc.. Reason: Tablets/Capsules Imprinted with Wrong ID.
Details
Source
Drug Recall
External ID
D-0306-2026
Action Date
2026-02-18
Status
Ongoing
Category
drug
Product 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.
Lot/Code Info: Lot # GDSH25006, Exp Date: 08/2027
Quantity Affected: 60,000 tablets
Reason for Recall
Tablets/Capsules Imprinted with Wrong ID
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-21
Company
East Brunswick, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 73 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Unichem Pharmaceuticals USA Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Unichem Pharmaceuticals USA Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Unichem Pharmaceuticals USA Inc. have FDA actions?
Unichem Pharmaceuticals USA Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0306-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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