PRIMIDONE
Recalling Firm / Manufacturer: Golden State Medical Supply Inc.
(Camarillo, CA, United States)
FDA Recall Number: D-0535-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
PRIMIDONE
Generic Name
PRIMIDONE
Active Substance(s)
Primidone
Administration Route
Oral
National Drug Code (NDC)
51407-637
Total Quantity Recalled
1,620 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
May 27, 2026
Firm Initiation Date
April 27, 2026
FDA Classification Date
May 18, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
Distribution Information
Geographic scope of affected shipments
USA Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0535-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508603UTCC