FDA Issues Class I Recall for Levetiracetam Injection Due to Labeling Discrepancy

Dr Reddy’s Laboratories Inc. has initiated a Class I recall of levetiracetam 0.75% in sodium chloride injection following the discovery of a labeling discrepancy that could pose serious health risks. Specifically, infusion bags from lot A1540076, labeled as containing 500 mg/100 mL of levetiracetam in 0.82% sodium chloride, actually contain 1000 mg/100 mL in 0.75% sodium chloride, as correctly indicated on the aluminum overwrap. The mislabeled infusion bag may lead to administration of a significantly higher dose than intended if clinicians rely solely on the bag label.

The recall, announced on March 13, 2025, and classified by the US Food and Drug Administration (FDA) on April 16, 2025, affects 4010 units distributed nationwide across the US. Given the potential for serious adverse events—including toxicity from overdose or underdose in patients depending on accurate dosing—the FDA designated this as a Class I recall, the most urgent classification, indicating a reasonable probability that use of the product could result in serious health consequences or death. The product was manufactured by Gland Pharma Limited in India and distributed by Dr Reddy’s Laboratories from its Princeton, New Jersey location.

Levetiracetam injection is an antiepileptic drug used in the treatment of partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in individuals with epilepsy. Intravenous administration is typically used in settings where oral administration is not feasible, emphasizing the importance of precise dosing. Pharmacists and health care professionals are advised to check inventory and immediately discontinue use of the affected lot to avoid potential dosing errors.