Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Tamsulosin Hydrochloride Capsules Recalled by Ascend Laboratories LLC Due to Failed Dissolution Specifications: High Out-of-Specification dissolution results were...

Date: February 22, 2019
Company: Ascend Laboratories LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ascend Laboratories LLC directly.

Affected Products

Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05.

Quantity: 3,072 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ascend Laboratories LLC

Ascend Laboratories LLC has 15 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report