Lacosamide Tablet, Film Coated
FDA Recall NDC 31722-812
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 Lacosamide (NDC 31722-812). A significant event, classified as Class II, was initiated on Jun 04, 2026 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg."
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
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Jun 04, 2026
Jul 01, 2026
31,392 60-count bottles
Recall Profile & Regulatory Data
Event ID
99200
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Annora Pharma Private Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.
Batch or Lot Expiration Information
Lot# Lot: A253999, A254000, Expires: 09/30/2027.
Affected Packages Involved in this Recall
31722-812-60Product
31722-812-18Product
31722-812-05Product
31722-812-32Product
31722-813-60Product
31722-813-18Product
31722-813-05Product
31722-813-32Product
31722-814-60Product
31722-814-18Product
31722-814-05Product
31722-814-32Product
31722-815-60Product
31722-815-18Product
31722-815-05Product
31722-815-32Product
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.
