February 2025 FDA Recall Prasugrel by Mylan Pharmaceuticals Inc
D-0280-2025 - Failed Dissolution Specifications - low dissolution results
This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc on February 25, 2025 for the product Prasugrel. The FDA reported the reason for recall as failed dissolution specifications - low dissolution results. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0280-2025
Failed Dissolution Specifications - low dissolution results
02-25-2025
03-26-2025
N/A
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
MYLAN PHARMACEUTICALS INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 3211073, 3211074, 3211075, Exp 4/30/2026
