FDAClass IIMarch 26, 2025

Prasugrel Tablets recall: Failed Dissolution

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

Why was Prasugrel Tablets recalled?

Failed Dissolution Specifications - low dissolution results

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
MYLAN PHARMACEUTICALS INC
Quantity
N/A
Distribution
US Nationwide.
Recall date
March 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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