Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Tamsulosin recalled?

Not under an active recall. Tamsulosin was recalled 5 times in the past — all now closed. Most recent: Jul 17, 2019.

Most common reason: Dissolution failure (3 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Tamsulosin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Tamsulosin recalls on record

none so far in 2026; 5 on record, newest first
Class II · Moderate risk

Tamsulosin Hydrochloride Capsules

Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.

Terminated Dissolution failure Ascend Laboratories LLC NDC 67877-450-05 D-1066-2019
Class II · Moderate risk

Dutasteride and Tamsulosin HCl Capsules

Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.

Terminated Dissolution failure Teva Pharmaceuticals USA NDC 0591-3771-30 D-0069-2018
Class II · Moderate risk

Tamsulosin Base active pharmaceutical ingredient packaged in…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-914-2015