Lacosamide Tablets Recalled Due to the Presence of Foreign Tablets

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for lacosamide tablets, USP, 100 mg. The affected batches have been identified as Lots A253999 and A254000 (expiration September 2027), affecting 31 392 bottles.
• The recall was initiated by Annora Pharma Private, Ltd due to the presence of foreign tablets, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Lacosamide is used to treat partial-onset and primary generalized tonic-clonic seizures.

The FDA has issued a Class II recall for lacosamide tablets, USP, 100 mg, affecting 31 392 bottles. This medication is manufactured and recalled by Annora Pharma Private, Ltd based in India. The recall was initiated on June 4, 2026, and received a Class II classification on June 25, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to the presence of foreign tablets; a bottle of lacosamide tablets was possibly mixed with selexipag 1000 mcg tablets. This deficiency affects Lots A253999 and A254000, which will expire in September 2027. Annora Pharma sent out a public notice via email; no press release has been issued for this recall.

Lacosamide is a prescription medication used to treat partial-onset and primary generalized tonic-clonic seizures. Pharmacists should identify and quarantine Lots A253999 and A254000, remove them from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. July 1, 2026. Accessed July 1, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221039