Perampanel Tablet, Film Coated
FDA Recall NDC 51672-4204
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 Perampanel (NDC 51672-4204). A significant event, classified as Class II, was initiated on Jun 17, 2026 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets."
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 II Ongoing
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Jun 17, 2026
Jul 01, 2026
3,456 30-count bottles
Recall Profile & Regulatory Data
Event ID
99256
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6
Batch or Lot Expiration Information
Lot# Lot AE01763, Expires 9/30/2027.
Affected Packages Involved in this Recall
51672-4205-6Product
51672-4205-2Product
51672-4204-6Product
51672-4204-3Product
51672-4206-6Product
51672-4206-2Product
51672-4207-6Product
51672-4207-2Product
51672-4208-6Product
51672-4208-2Product
51672-4209-6Product
51672-4209-2Product
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.
