Mylan Pharmaceuticals Inc recalls Prasugrel Tablets
- Recalling company
- Mylan Pharmaceuticals Inc
- 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
- Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 17, 2026
- Reported
- Sep 9, 2026
- Distribution
- Nationwide within the U.S
- Status
- Ongoing
- Quantity
- 47,662 bottles
- Lot / codes
- Lot #: 3225272, Exp. September 30, 2026
- Company location
- Morgantown, WV
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0839-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0839-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.