The Recall Desk
HighFDA (Drugs)·D-0280-2025·Announced 2025-03-26

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.

What this means for you

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
  • dissolution-failure

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.

Related recalls

Same brand · PRASUGREL

Same category