FDA Drugs recall ·
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only… recall
- Recall number
- D-0280-2025
- Date
- (initiated February 25, 2025)
- Company / brand
- Mylan Pharmaceuticals Inc
1311 Pineview Dr, Morgantown, WV, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Failed Dissolution Specifications - low dissolution results
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 3211073, 3211074, 3211075, Exp 4/30/2026
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0280-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.