Drug recall: Dr. Reddy’s Recalls Levetiracetam in 0.75% Sodium Chloride Injection Due to this reason

Last Updated on March 23, 2025 by The Health Master

Drug recall

Dr. Reddy’s Laboratories Ltd. has issued a nationwide drug recall of Levetiracetam in 0.75% Sodium Chloride Injection due to the mislabeling of the infusion bag.

Summary

• Company Announcement Date: March 13, 2025
• USFDA Publish Date: March 13, 2025
• Product Type: Drugs
• Reason for Announcement: Mislabeling of infusion bag
• Company Name: Dr. Reddy’s Laboratories Ltd.
• Brand Name: Dr. Reddy’s
• Product Description: Levetiracetam in Sodium Chloride Injection

Company Announcement

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”) 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.

Reason for the drug recall

The drug recall is being done 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.

Risk Statement

Patients who are administered the mislabeled product will likely experience adverse events.

Because the infusion bag is labeled as 500 mg/100 mL but actually contains a 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, a depressed level of consciousness, respiratory depression, and coma.

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 drug recall.

Indication

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

Packing of the drug

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

Identification information such as lot number, expiration date, and NDC is presented in the table below.

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

Description of the drug recall:

NDC Number	Product OverwrapDescription	Product Infusion BagPrimary 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 mL10 Single-Dose Bags	A1540076	08/2026

Dr. Reddy’s Laboratories, Inc is notifying its distributors and customers to arrange for the 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 that may have received the product from them.

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 drug 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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This drug recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).

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