Levetiracetam

EYWA PHARMA INC initiated a Class II recall (D-0109-2021) for 5,451 bottles of Levetiracetam Tablets, USP 500 mg, due to 1000 mg tablets found in 500 mg bottles. This critical quality control failure, originating from Indian manufacturer VKT Pharma, underscores significant supply chain risks for procurement and regulatory teams. The recall, initiated November 2020, was terminated October 2024, indicating resolution but demanding continued vigilance.

Gland Pharma Limited has secured a recent labeling approval for its generic Levetiracetam Injection (ANDA206880), with an effective date of March 26, 2025. This intravenous antiepileptic drug, also manufactured by Dr. Reddy's Laboratories Inc and Sagent Pharmaceuticals, reinforces supply chain resilience and cost-effective access for critical neurological care. Procurement and regulatory teams should note the ongoing product lifecycle management.