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FDAClass II

Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan… Recalled: Failed Dissolution Specifications; product failed to meet 18-month stability testing acce…

Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each… was recalled on August 17, 2026 in cooperation with the U.S. Food and Drug Administration because failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria.

Is my unit affected?

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.

Model, lot & date codes to check

Lot #: 3225272, Exp. September 30, 2026

Units affected: 47,662 bottles

Where it was sold: Nationwide within the U.S

Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.

What's the hazard?

Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.

Your remedy & how to claim it

Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.

Contact: Recalling firm: Mylan Pharmaceuticals Inc

Not sure what you're entitled to? Read our guide: what to do if your product is recalled.

Official recall notice

Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.

View official notice →

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