Doxazosin Mesylate Tablet
FDA Recall NDC 29300-352
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Doxazosin Mesylate (NDC 29300-352). A significant event, classified as Class III, was initiated on Jan 21, 2026 by Unichem Pharmaceuticals (usa), Inc.. The reported reason for this action was: "Tablets/Capsules Imprinted with Wrong ID"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Tablets/Capsules Imprinted with Wrong ID
Jan 21, 2026
Feb 18, 2026
60,000 tablets
Recall Profile & Regulatory Data
Event ID
98321
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Unichem Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
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.
Batch or Lot Expiration Information
Lot# GDSH25006, Exp Date: 08/2027
Affected Packages Involved in this Recall
29300-351-13Product
29300-351-01Product
29300-351-10Product
29300-352-13Product
29300-352-01Product
29300-352-10Product
29300-353-13Product
29300-353-01Product
29300-353-10Product
29300-354-13Product
29300-354-01Product
29300-354-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
