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D-0280-2025Class II

MYLAN PHARMACEUTICALS INC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
MYLAN PHARMACEUTICALS INC
Product type
Drug
Status
Ongoing
Report date
2025-03-26
Distribution
US Nationwide.
Firm state
WV
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Dissolution Specifications - low dissolution results

Product description

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

Code / lot info

Lot # 3211073, 3211074, 3211075, Exp 4/30/2026

Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →