Primidone Tablet
FDA Recall NDC 53746-544
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 53746-544). A significant event, classified as Class III, was initiated on Jun 03, 2026 by Amneal Pharmaceuticals Of New York Llc. The reported reason for this action was: "Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer."
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: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Jun 03, 2026
Jun 17, 2026
27,936 100-count bottles
Recall Profile & Regulatory Data
Event ID
99146
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA.
Product Description
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Batch or Lot Expiration Information
Lot# Lot AM251676, EXP 11/31/2028
Affected Packages Involved in this Recall
53746-544-01Product
53746-544-10Product
53746-544-05Product
53746-545-01Product
53746-545-10Product
53746-545-05Product
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.
