CLASS II ONGOING Drug recall · Reported 9 Sep 2026 · FDA Enforcement Report
Prasugrel Tablets, USP, 10mg recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling Prasugrel Tablets, USP, 10mg, distributed nationwide in the US. The recall was initiated on 17 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0839-2026
- FDA event ID
- 99653
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Brand
- Prasugrel
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Aug 2026
- FDA classified
- 11 Sep 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 17 Aug 2026 | Recall initiated by company | |
| 9 Sep 2026 | Published in enforcement report | +23 days |
| 11 Sep 2026 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the U.S
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Which lots are affected?
Lot #: 3225272, Exp. September 30, 2026
Where was it sold?
Nationwide within the U.S
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Prasugrel Tablets, USP, 5 mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Prasugrel recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Prasugrel Tablets, 5 mg recalled by Golden State Medical SupplyPrasugrel | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Prasugrel Tablets, USP, 5 mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Prasugrel Tablets 5 mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |