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Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured Recall 2026

PRASUGRELIssued August 17, 2026Updated Reviewed by the Recall Watch editorial team

PRASUGREL 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. — recalled per FDA on 8/17/2026. Reason: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria.

Agency
FDA
Issued
Aug 17, 2026
Brand
PRASUGREL
Distribution
1 states
Lots affected
3
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued August 17, 2026 · Last synced Nov 1, 2026

What's recalled

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.

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Why it was recalled

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

Affected products & lot numbers
3 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot #: 3225272
Exp. September 30
2026
Where was it sold
1 state

Nationwide within the U.S

nationwide
Official noticefda.gov
More recalls like this
5 related — by brand, contaminant, and category

Frequently asked questions

Is the PRASUGREL recall still active?

Yes, this recall is currently active as of August 17, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot #: 3225272, Exp. September 30, 2026. Check the label on your product.

What should I do if I have the recalled PRASUGREL?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.