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Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by GSMS Recall 2026

PRASUGRELIssued August 21, 2026Updated Reviewed by the Recall Watch editorial team

PRASUGREL Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30. — recalled per FDA on 8/21/2026. Reason: Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution.

Agency
FDA
Issued
Aug 21, 2026
Brand
PRASUGREL
Distribution
1 states
Lots affected
2
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.

Verified summary of the official U.S. Food and Drug Administration notice · Issued August 21, 2026 · Last synced Nov 1, 2026

What's recalled

Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.

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Why it was recalled

Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

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

Lot Number
Lot # GS062298
Exp Date: 09/30/ 2026.
Where was it sold
1 state

US Nationwide.

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 21, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot # GS062298, Exp Date: 09/30/ 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.