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.
Class II · Ongoing
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
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Affected lots / codes — check yours against thisLot #: 3225272, Exp. September 30, 2026
- Recalling firm
- Mylan Pharmaceuticals Inc, Morgantown, WV
- Classification
- Class II (temporary or reversible harm possible)
- Status
- Ongoing
- Quantity
- 47,662 bottles
- Distribution
- Nationwide within the U.S
- Recall initiated
- August 17, 2026
- Classified
- September 11, 2026
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0839-2026%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0839-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →