Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morganto
Summary
The FDA issued a Class II for Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured f by Mylan Pharmaceuticals Inc. Reason: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria.
Details
Source
Drug Recall
External ID
D-0839-2026
Action Date
2026-09-09
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot #: 3225272, Exp. September 30, 2026
Quantity Affected: 47,662 bottles
Reason for Recall
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Distribution
Nationwide within the U.S
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-17
Company
Morgantown, WV
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 53 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Mylan Pharmaceuticals Inc has 12 FDA actions in our database, including 12 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mylan Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mylan Pharmaceuticals Inc have FDA actions?
Mylan Pharmaceuticals Inc has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0839-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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