Drug FDA Class III Ongoing Chemical
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
Golden State Medical Supply Inc. Published May 27, 2026
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 48/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Golden State Medical Supply Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Hazards
Acemetacin API contamination · primary
Affected products (1)
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
PRIMIDONE · 1,620 bottles
NDC: 51407-637, 51407-638, 51407-637-01, 51407-637-05, 51407-638-01
Code info: Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
Affected areas
Nationwide
Timeline
- InitiatedApr 27, 2026
- PublishedMay 27, 2026
- Recall number
- D-0535-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.