FDA recall, , Moderate risk
Mylan Prasugrel Tablets
Prasugrel Tablets, USP, 10mg failed dissolution specifications and stability testing.
Summary by Recall Canary from the FDA notice
What happened
Mylan Pharmaceuticals Inc., of Morgantown, West Virginia, is recalling Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, because the product failed dissolution specifications and did not meet 18-month stability testing acceptance criteria. The recall began on August 17, 2026, and the product was distributed nationwide within the U.S.
The affected tablets are manufactured for Mylan Pharmaceuticals Inc. and made in India. The FDA added the recall to its Enforcement Report on August 28, 2026, and classified it on September 11, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Prasugrel Tablets, USP, 10mg
- NDC
- 0378-5186-93
- Lot code
- 3225272
Recall details
- Company began the recall
- Sold in
Nationwide within the U.S
- Company
- MYLAN PHARMACEUTICALS INCMorgantown, West Virginia
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99653
- Recall number
- D-0839-2026
- Quantity recalled
- 47,662 bottles
All recalls from MYLAN PHARMACEUTICALS INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
