DOXAZOSIN MESYLATE
Recalling Firm / Manufacturer: Unichem Pharmaceuticals USA Inc.
(East Brunswick, NJ, United States)
FDA Recall Number: D-0306-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
DOXAZOSIN MESYLATE
Generic Name
DOXAZOSIN MESYLATE
Active Substance(s)
Doxazosin Mesylate
Administration Route
Oral
National Drug Code (NDC)
29300-351
Total Quantity Recalled
60,000 tablets
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Tablets/Capsules Imprinted with Wrong ID
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
February 18, 2026
Firm Initiation Date
January 21, 2026
FDA Classification Date
Feb 11, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # GDSH25006, Exp Date: 08/2027
Distribution Information
Geographic scope of affected shipments
Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0306-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC