Dr Reddy's Labs recalls epilepsy drug in US over infusion bag mislabeling

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-03-17 11:58 GMT   |   Update On 2025-03-17 11:58 GMT

Hyderabad: Dr Reddy’s Laboratories Ltd., is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level, in the United States.

The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

"Patients who are administered the mislabeled product will likely experience adverse events. Because the infusion bag is labelled as 500 mg/100 mL but actually contains 1,000 mg/100 mL dose, the patient could receive double the dose of intravenous levetiracetam than intended which could lead to immediate and serious side effects including hypersensitivity reactions, liver injury, hematological toxicity, somnolence, fatigue, dizziness, coordination difficulties, agitation, aggression, depressed level of consciousness, respiratory depression, and coma," the company informed.

Patients receiving high doses of levetiracetam by rapid intravenous infusion for the treatment of status epilepticus would be most at risk for severe adverse events. Dr. Reddy’s has not received any reports of adverse events related to this recall.

Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) and Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg/100 mL (5mg/mL) are both indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible:

-Partial onset seizures

- Myoclonic seizures in patients with juvenile myoclonic epilepsy

- Primary generalized tonic-clonic seizures

Each product is packaged in single-dose infusion bags with an aluminum overwrap, 10 single-dose bags packed in a carton. 

The batch was distributed nationwide between November 4, 2024, and November 6, 2024, to wholesalers.

DESCRIPTION OF MISLABELLED BAGS BEING RECALLED:

NDC Number

Product Overwrap Description

Product Infusion Bag Primary Description

Lot Number

Expiration Date

43598-635-52

Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL

Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag.

A1540076

08/2026

43598-636-52

Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL

Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL single-dose bag

A1540076

08/2026

DESCRIPTION OF CARTON BEING RECALLED:

NDC Number

Carton Description

Lot Number

Expiration Date

43598-636-10

Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL

10 Single-Dose Bags

A1540076

08/2026


"Dr. Reddy’s Laboratories, Inc is notifying its distributors and customers to arrange for return of any recalled product. Wholesalers, distributors, hospitals, and pharmacies with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately for return/replacement of all recalled products. Wholesalers, distributors, and pharmacies that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them," the company added.
"For instructions on returning product or additional assistance, call Inmar at 1-877-645-1584 between the hours of 9 a.m. to 5 p.m. ET, Monday through Friday. Consumers with questions regarding this recall can contact Dr. Reddy’s Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 8 p.m. ET, Monday through Friday. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.  This recall is being executed with the knowledge of the U.S. Food and Drug Administration," Dr Reddys stated.
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