Primidone Tablet
FDA Recall NDC 68084-202
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 68084-202). A significant event, classified as Class III, was initiated on May 01, 2026 by American Health Packaging. 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.
May 01, 2026
May 27, 2026
63,500 tablets
Recall Profile & Regulatory Data
Event ID
98884
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Batch or Lot Expiration Information
Lot# : 1027583, Exp 09/30/2027
Affected Packages Involved in this Recall
68084-203-11Product
68084-203-01Product
68084-202-11Product
68084-202-01Product
Class III Ongoing
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
May 01, 2026
May 27, 2026
225,000 tablets
Recall Profile & Regulatory Data
Event ID
98884
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Batch or Lot Expiration Information
Lot# Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
Affected Packages Involved in this Recall
68084-203-11Product
68084-203-01Product
68084-202-11Product
68084-202-01Product
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.
