FDARecall 99653Medicines
What to do
The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.
Read the official notice on accessdata.fda.gov (opens in a new tab)
Hazard
Why it was recalled
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
FDA classification: Class II. Use may cause temporary or medically reversible health consequences, or the chance of serious consequences is remote. Status: Ongoing.
Is it yours? Products and codes
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.
- Lot or code
- Lot #: 3225272, Exp. September 30, 2026
- FDA recall number
- D-0839-2026
- Quantity
- 47,662 bottles
Distribution (FDA): Nationwide within the U.S
About this record
- Issued by
- U.S. Food and Drug Administration
- Firm
- Mylan Pharmaceuticals Inc (other notices of this firm)
- Title
- Composed by Recalls Watch from fields of the record; FDA records have no title.