FDAFDA · Food and drugs·Recall number D-0839-2026
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.
Published September 9, 2026 · Recall initiated: August 17, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PRASUGREL
- Manufacturer
- Mylan Pharmaceuticals Inc
- Distributor
- Nationwide within the U.S
- UPC
- 0303785185932
- Lot
- Lot #: 3225272, Exp. September 30, 2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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