Dr. Reddy's Laboratories, Inc. recalls Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland…

Recall date

March 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0365-2025

FDA classification

Class I

Brand / firm

Dr. Reddy's Laboratories, Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52