Prasugrel 5 mg Tablets Recalled Due to Failed Dissolution Specifications
Mylan Pharmaceuticals is recalling specific lots of Prasugrel 5 mg tablets due to failed dissolution specifications. The affected tablets may not dissolve properly in the body.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving failed dissolution specifications in a prescription medication, with no reported illnesses or injuries. The manufacturing defect poses a risk of reduced drug effectiveness, meeting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling specific lots of Prasugrel 5 mg tablets due to failed dissolution specifications. Testing identified that tablets in the affected lots did not meet required dissolution standards.
The recall affects Prasugrel 5 mg tablets distributed nationwide. The affected lot numbers are 3211073, 3211074, and 3211075, all with an expiration date of 4/30/2026. The product is identified by NDC 0378-5185-93.
Patients currently taking Prasugrel from the affected lots should contact their healthcare provider or pharmacist to discuss their medication supply and determine appropriate next steps.
The recalled product
- Product
- PRASUGREL (PRASUGREL)
- Brand
- PRASUGREL
- Manufacturer
- MYLAN PHARMACEUTICALS INC
- Category
- Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # 3211073
- 3211074
- 3211075
- Exp 4/30/2026
UPCs (1)
- 0303785185932
Distribution
Distributed nationwide across the United States.
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