Prasugrel Tablets recall (Mylan Pharmaceuticals Inc)
DrugClass IIOngoing
Summary: Mylan Pharmaceuticals Inc is recalling 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.
What is being recalled
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
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the U.S
How to tell if yours is affected
Lot #: 3225272, Exp. September 30, 2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0839-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 17, 2026 |
| Reported | September 9, 2026 |
| Company | Mylan Pharmaceuticals Inc |
| Company location | Morgantown, WV, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 47,662 bottles |
More recalls from Mylan Pharmaceuticals Inc · all drug recalls · recalls from August 2026