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Drug FDA Class III Ongoing Chemical

Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05

Golden State Medical Supply Inc. Published May 27, 2026

Risk level

Class III

Unlikely 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, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05

PRIMIDONE · 8,526 bottles

NDC: 51407-637, 51407-638, 51407-637-01, 51407-637-05, 51407-638-01
Code info: Lot#: GS066750, GS067084, GS067710, GS067873, Exp 3/31/2028; GS068339, GS068897, Exp 8/31/2028

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 27, 2026
  2. Published
    May 27, 2026
Recall number
D-0534-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

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.