FDA Drugs recall ·
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle… recall
- Recall number
- D-0839-2026
- Date
- (initiated August 17, 2026)
- Company / brand
- Mylan Pharmaceuticals Inc
3711 Collins Ferry Rd, Morgantown, WV, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 47,662 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
Why was it recalled?
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
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 #: 3225272, Exp. September 30, 2026
Distribution
Nationwide within the U.S
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-0839-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.