FDA recall, , Moderate risk
GSMS Prasugrel HCI Tablets
Prasugrel tablets failed dissolution specifications.
Summary by Recall Canary from the FDA notice
What happened
Golden State Medical Supply Inc., of Camarillo, California, recalled Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, marketed by GSMS, Incorporated, after the manufacturer notified the company that the lot failed dissolution specifications. The recall began on August 21, 2026, and was added to the FDA's Enforcement Report on August 28, 2026. The product was distributed nationwide in the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle
- NDC
- 51407-445-30
- Lot code
- GS062298
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Golden State Medical Supply Inc.Camarillo, California
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99732
- Recall number
- D-0847-2026
All recalls from Golden State Medical Supply Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
