FDA recall, , Moderate risk
Golden State Medical Supply Niacin Extended-Release Tablets
Niacin extended-release tablets failed dissolution specifications during stability testing.
Summary by Recall Canary from the FDA notice
What happened
Golden State Medical Supply Inc. of Camarillo, California, recalled GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, because the lot failed dissolution specifications during 12-month long-term stability testing, being out of specification for stage 3 dissolution at the 24-hour timepoint.
The tablets were manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, and packaged by GSMS Incorporated. The recall began May 29, 2026, and was added to the FDA's Enforcement Report on June 11, 2026. The product was distributed within the U.S. market.
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 yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Niacin Extended-Release Tablets, USP, 1,000 mg
- NDC
- 51407-268-90
- Lot code
- GS065128
- GS065844
- GS066695
- GS067432
- GS067993
Recall details
- Company began the recall
- Sold in
Within the U.S Market.
- 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
- 99127
- Recall number
- D-0587-2026
- Quantity recalled
- 2,961 bottles
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 · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
