Class II · Moderate risk
Prasugrel HCI
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Prasugrel Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications - low dissolution results
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
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
Affected NDC
0378-5185-93
Compare with the code on your package — it is the most precise check available.
Drug: Prasugrel
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Prasugrel NDC 00378-5185 |
HYDROCHLORIDE 5 mg/1 | Tablet, Film Coated Oral |
Mylan Pharmaceuticals Inc. | Rx |
- Recalling firm
- Mylan Pharmaceuticals INC
- NDC code
- 0378-5185-93
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0280-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Prasugrel recalls
See all
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Prasugrel Tablets 5 mg
Failed Dissolution Specification: Low out of specification dissolution results.
Other recalls by Mylan Pharmaceuticals INC
All 2025 recalls
Class II · Moderate risk
Carton label: Mycophenolate Mofetil for injection
Failed Dissolution Specifications
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Class II · Moderate risk
Acamprosate Calcium
Failed Dissolution Specifications
Class II · Moderate risk
Mycophenolate Mofetil for Injection USP
Presence of precipitate
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