Primidone Tablet
FDA Recall NDC 51407-637
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Primidone (NDC 51407-637). A significant event, classified as Class III, was initiated on Apr 27, 2026 by Golden State Medical Supply, Inc. The reported reason for this action was: "Cross contamination with other products: API contaminated with trace amounts of Acemetacin API."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Apr 27, 2026
May 27, 2026
8,526 bottles
Recall Profile & Regulatory Data
Event ID
98856
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# : GS066750, GS067084, GS067710, GS067873, Exp 3/31/2028; GS068339, GS068897, Exp 8/31/2028
Affected Packages Involved in this Recall
51407-637-01Product
51407-637-05Product
51407-638-01Product
Class III Ongoing
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Apr 27, 2026
May 27, 2026
1,620 bottles
Recall Profile & Regulatory Data
Event ID
98856
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# : GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
Affected Packages Involved in this Recall
51407-637-01Product
51407-637-05Product
51407-638-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
