Unichem Pharmaceuticals Issues Nationwide Recall of Doxazosin Mesylate Tablets Due to Incorrect Imprint
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Unichem Pharmaceuticals USA Inc. is recalling 60,000 Doxazosin tablets after discovering the medication was imprinted with the incorrect identification code.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Pharmaceuticals.
What Happened
Unichem Pharmaceuticals USA Inc. has initiated a voluntary recall of Doxazosin Tablets, USP, 4 mg. The recall was prompted by the discovery that the tablets were imprinted with the wrong identification (ID) code. The FDA has classified this as a Class III recall, which typically involves products that are unlikely to cause adverse health consequences but violate labeling or manufacturing standards.
Which Products Are Affected
The recall affects a specific lot of Doxazosin Tablets distributed nationwide across the United States. Details include:
- Product Name: Doxazosin Tablets, USP, 4 mg (Rx only)
- Manufacturer: Unichem Laboratories Limited (India)
- Distributor: Unichem Pharmaceuticals (USA), Inc.
- NDC Number: 29300-353-10
- Lot Number: GDSH25006
- Expiration Date: 08/2027
- Quantity: 60,000 tablets (1,000 tablets per bottle)
- Recall Number: D-0306-2026
What You Should Do
Consumers, pharmacists, and healthcare providers should immediately check their stock for the affected lot number (GDSH25006). The firm initiated the recall process via notification letters. If you possess the affected product, you should follow the instructions provided in the manufacturer's letter regarding the return or disposal of the medication. For further inquiries, Unichem Pharmaceuticals USA Inc. is located in East Brunswick, NJ.
Why This Matters
Accurate imprinting on prescription medication is critical for ensuring that patients, caregivers, and healthcare professionals can correctly identify the drug and dosage. While this specific defect is not expected to cause health issues, maintaining strict identification standards is vital for patient safety.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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