Prasugrel Tablets recall: Failed Dissolution
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India…
Why was Prasugrel Tablets recalled?
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 3225272, Exp. September 30, 2026
- Product
- Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India…
- Recalling firm
- Mylan Pharmaceuticals Inc
- Quantity
- 47,662 bottles
- Distribution
- Nationwide within the U.S
- Recall date
- September 9, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)