Class IIDrug
Prasugrel Tablets recall
Summary
Mylan Pharmaceuticals Inc is recalling Prasugrel Tablets (drug). According to the FDA report, the reason is: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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
- Lot / code info
- Lot #: 3225272, Exp. September 30, 2026
- Quantity
- 47,662 bottles
- Distribution
- Nationwide within the U.S
- Recalling company
- Mylan Pharmaceuticals Inc, Morgantown, WV United States
- Recall started
- August 17, 2026
- FDA report date
- September 9, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0839-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Mylan Pharmaceuticals Inc) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.