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Drug FDA Class II Ongoing Failed specifications

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

MYLAN PHARMACEUTICALS INC Published Mar 26, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact MYLAN PHARMACEUTICALS INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications - low dissolution results

Hazards

Failed Dissolution · primary

Affected products (1)

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

PRASUGREL · N/A

NDC: 0378-5185, 0378-5186, 0378-5185-93, 0378-5186-93
Lot codes: 3211073
Code info: Lot # 3211073, 3211074, 3211075, Exp 4/30/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 25, 2025
  2. Published
    Mar 26, 2025
Recall number
D-0280-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.