Prasugrel Tablets recall
FDA recall D-0839-2026 · initiated Aug 17, 2026
Mylan Pharmaceuticals Inc recalled Prasugrel Tablets in Aug 2026 — an FDA Class II recall (D-0839-2026) because Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 47,662 bottles
Details
- Product
- 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.
- Recalling company
- Mylan Pharmaceuticals Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the U.S
- Initiated
- Aug 17, 2026
- FDA report date
- Sep 9, 2026
Frequently asked
- Was Prasugrel Tablets recalled?
- Mylan Pharmaceuticals Inc recalled Prasugrel Tablets in Aug 2026 — an FDA Class II recall (D-0839-2026) because Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Prasugrel Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0839-2026 was: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
- Is a recalled Prasugrel Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Prasugrel Tablets are affected?
- Distributed: Nationwide within the U.S. The recall covers these lots — Lot #: 3225272, Exp. September 30, 2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0839-2026.