FDAClass IISeptember 9, 2026

Prasugrel HCI recall: Failed Dissolution

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

Why was Prasugrel HCI recalled?

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

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 # GS062298, Exp Date: 09/30/ 2026.

Product
Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.
Recalling firm
Golden State Medical Supply Inc.
Quantity
6791 30-count bottles
Distribution
US Nationwide.
Recall date
September 9, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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