August 2026 FDA Recall Prasugrel by Mylan Pharmaceuticals Inc
D-0839-2026 - Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc on August 17, 2026 for the product Prasugrel. The FDA reported the reason for recall as failed dissolution specifications; product failed to meet 18-month stability testing acceptance criteria. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0839-2026

Reason for Recall
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Initiated
08-17-2026
Reported
09-09-2026
Quantity
47,662 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99653
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Ongoing
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the U.S
Product Description About Product Description
Full technical description of the product.
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.

Batch or Lot Expiration Information

Lot# : 3225272, Exp. September 30, 2026

Affected Packages Involved in this Recall

0378-5185-93 Prasugrel
0378-5186-93 Prasugrel