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.

Prasugrel Tablets 5 mg Recalled by Mylan Pharmaceuticals Inc. Due to Failed Dissolution Specification: Low out of specification dissolution...

Date: October 18, 2019
Company: Mylan Pharmaceuticals Inc.
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 Mylan Pharmaceuticals Inc. directly.

Affected Products

Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93

Quantity: 4,272 bottles

Why Was This Recalled?

Failed Dissolution Specification: Low out of specification dissolution results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mylan Pharmaceuticals Inc.

Mylan Pharmaceuticals Inc. has 71 total recalls tracked by RecallDetector.

Related Recalls

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