Doxazosin tablets recalled after being imprinted with the wrong identifier
Unichem Pharmaceuticals USA is recalling 60,000 Doxazosin Tablets, USP 4 mg, because the tablets are imprinted with the wrong ID.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites an incorrect tablet imprint with no stated clinical consequence.
Plain-English summary
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, manufactured by Unichem Laboratories Limited of Goa, India and distributed by Unichem Pharmaceuticals (USA), Inc. of East Brunswick, New Jersey, under NDC 29300-353-10, are being recalled.
The reason given in the enforcement record is that the tablets or capsules are imprinted with the wrong ID.
The record lists 60,000 tablets from lot GDSH25006, expiry 08/2027. Distribution was nationwide. The FDA has classified the action as Class III, its least serious category.
An imprint that does not match the product can make a tablet harder to identify. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected.
The recalled product
- Product
- DOXAZOSIN MESYLATE (DOXAZOSIN MESYLATE)
- Brand
- DOXAZOSIN MESYLATE
- Manufacturer
- Unichem Pharmaceuticals USA Inc.
- Category
- Drug — Antihypertensive
- Affected units
- 60,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # GDSH25006
- Exp Date: 08/2027
Distribution
Distributed nationwide across the United States.
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