Prasugrel HCI 10 mg 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.
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Prasugrel HCI 10 mg 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?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.
Which lot codes, UPCs or models are affected?
Lot # GS062298, Exp Date: 09/30/ 2026.
- Agency record number
- D-0847-2026
- 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 started
- August 21, 2026
- Report date
- September 9, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)