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 Recalled by MYLAN PHARMACEUTICALS INC Due to Failed Dissolution Specifications - low dissolution results

Date: February 25, 2025
Company: MYLAN PHARMACEUTICALS INC
Status: Ongoing
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, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93

Quantity: N/A

Why Was This Recalled?

Failed Dissolution Specifications - low 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 2 total recalls tracked by RecallDetector.

Related Recalls

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