Mylan Pharmaceuticals recall: Prasugrel Tablets
Mylan Pharmaceuticals Inc is recalling Prasugrel Tablets – 47,662 bottles. The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on August 17, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Prasugrel Tablets |
| Brand | Mylan Pharmaceuticals |
| Company | Mylan Pharmaceuticals Inc |
| Type | Drugs |
| Classification | Class II |
| Recall date | August 17, 2026 |
| Published by FDA | September 9, 2026 |
| Quantity | 47,662 bottles |
| Recall ID | 99653 |
Recalled products
- 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.
- FDA recall number
- D-0839-2026
- Codes, lots and dates
- Lot #: 3225272, Exp. September 30, 2026
- Quantity
- 47,662 bottles
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99653
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Morgantown, WV, United States
Why it was recalled
The reason the FDA lists: “Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria”
Where it was sold
Nationwide. Distribution as the FDA records it: “Nationwide within the U.S”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99653, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Mylan Pharmaceuticals recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 9, 2026 |  Mylan Pharmaceuticals recall: Carton label: Mycophenolate Mofetil for injectionDrugs · 11,336 units | Failed Dissolution Specifications Serious | FDA Class II |
| Aug 26, 2026 | Mylan Pharmaceuticals recall: Acamprosate CalciumDrugs | Failed Dissolution Specifications Serious | FDA Class II |
All 3 Mylan Pharmaceuticals recalls →
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 | Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
| Oct 7, 2026 | Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottles | Crystallization Serious | FDA Class II |
| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Mylan Pharmaceuticals Prasugrel Tablets recalled?
Yes. Mylan Pharmaceuticals Inc recalled it on August 17, 2026; FDA published it September 9, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.