FDAFDA recall D-0839-2026 · Sep 9, 2026
Mylan Pharmaceuticals Inc: Prasugrel Tablets recall
Recall found
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.
Reason for recall
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: 3225272, Exp. September 30, 2026
- Quantity
- 47,662 bottles
- Distribution
- Nationwide within the U.S
- Recalling firm
- Mylan Pharmaceuticals Inc, Morgantown, WV
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-17
Source: openFDA enforcement record D-0839-2026 · search recall number D-0839-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.