Doxazosin Tablets Recalled Due to Incorrect Tablet Imprint
Key Clinical Summary
- The US Food and Drug Administration (FDA) is monitoring a voluntary, firm‑initiated Class III recall of doxazosin tablets, USP, 4 mg, involving 60 000 tablets distributed nationwide and identified as Lot #GDSH25006 with an August 2027 expiration date.
- The recall was initiated by Unichem Pharmaceuticals (USA), Inc. after tablets were found to be imprinted with the wrong identifier, a labeling issue not expected to cause adverse health consequences.
- Doxazosin is an alpha‑1 adrenergic blocker indicated for the treatment of hypertension and benign prostatic hyperplasia (BPH), commonly used in outpatient cardiovascular and urologic care.
The FDA has classified a Class III recall for Doxazosin Tablets, USP, 4 mg, packaged in 1000-count bottles, due to a tablet imprint error. Specifically, tablets from Lot #GDSH25006 were imprinted with the wrong identifier, which could lead to confusion or dispensing errors. The affected lot has an expiration date of August 2027, and the recall includes 60 000 tablets. The product is distributed by Unichem Pharmaceuticals (USA), Inc., based in East Brunswick, NJ, and manufactured by Unichem Laboratories Limited in Goa, India.
This voluntary recall was initiated on January 21, 2026, and was officially classified as Class III by the FDA on February 11, 2026. A Class III recall is designated for products that are unlikely to cause adverse health consequences but violate FDA labeling or manufacturing standards. In this case, the incorrectly imprinted tablets may affect product identification and patient or pharmacist confidence, although no injuries or adverse events have been reported. Notification was issued to consignees via letter, and no press release has been made public.
Doxazosin is an alpha-1 adrenergic blocker used to treat hypertension and benign prostatic hyperplasia (BPH) by relaxing blood vessels and improving urine flow. Pharmacists should review inventory for Lot #GDSH25006 and remove affected bottles from shelves to prevent misidentification or patient confusion.
Reference
FDA. Enforcement Report. February 11, 2026. Accessed February 12, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm
