FDA-Drug2026-09-09Class IICHEMICAL
Mylan Prasugrel 10mg tablets recalled for failed dissolution specifications
What this means
Mylan Pharmaceuticals is recalling Prasugrel 10mg tablets (Lot #3225272, expiring September 30, 2026) because they failed dissolution testing during 18-month stability studies. This means the tablets may not break down and release the medication as intended in the body. No injuries have been reported.
- Check if you have Prasugrel 10mg tablets with lot #3225272 and expiration date September 30, 2026.
- Contact your pharmacist or doctor before stopping the medication—do not stop taking it without medical guidance.
- Return affected bottles to your pharmacy or follow your doctor's instructions for safe disposal.
The agency's original wording
Hazard
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
47,662 bottles
Manufactured in
3711 Collins Ferry Rd, N/A, Morgantown, WV, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0839-2026More Mylan recalls
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