Prasugrel Tablets recall
FDA recall D-0280-2025 · initiated Feb 25, 2025
MYLAN PHARMACEUTICALS INC recalled Prasugrel Tablets in Feb 2025 — an FDA Class II recall (D-0280-2025) because Failed Dissolution Specifications - low dissolution results.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications - low dissolution results
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: N/A
Details
- Product
- Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
- Recalling company
- Mylan Gmbh
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Feb 25, 2025
- FDA report date
- Mar 26, 2025
Frequently asked
- Was Prasugrel Tablets recalled?
- MYLAN PHARMACEUTICALS INC recalled Prasugrel Tablets in Feb 2025 — an FDA Class II recall (D-0280-2025) because Failed Dissolution Specifications - low dissolution results. 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-0280-2025 was: Failed Dissolution Specifications - low dissolution results
- 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: US Nationwide.. The recall covers these lots — Lot # 3211073, 3211074, 3211075, Exp 4/30/2026. 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-0280-2025.