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

Source: FDA · United States

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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 February 24, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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 ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Unichem Pharmaceuticals USA Inc. is recalling 60,000 Doxazosin tablets after discovering the medication was imprinted with the incorrect identification code.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.