Primidone Tablet
FDA Recall NDC 0527-1301
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Primidone (NDC 0527-1301). A significant event, classified as Class III, was initiated on Apr 24, 2026 by Lannett Company, 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 24, 2026
May 27, 2026
44865 bottles
Recall Profile & Regulatory Data
Event ID
98791
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Lannett Company Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Batch or Lot Expiration Information
Lot# : 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.
Affected Packages Involved in this Recall
0527-1301-01Product
0527-1301-05Product
0527-1301-10Product
0527-1231-01Product
0527-1231-05Product
0527-1231-10Product
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.
