Unichem Pharmaceuticals Issues Nationwide Recall of Doxazosin Mesylate Tablets Due to Incorrect Imprint

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.