RecallRadar
FDA · DrugsClass I

Dr. Reddy's Laboratories, Inc. drug recall: Levetiracetam 0.75% in Sodium Chloride Injection 1

Labeling errors

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Drugs
Classification
Class I
Status
Ongoing
Event ID
96470
Recall initiated
Mar 13, 2025
Classified by FDA
Apr 16, 2025
Posted in Enforcement Report
Apr 23, 2025
Recalling firm
Dr. Reddy's Laboratories, Inc.
Firm location
Princeton, NJ, United States
Initiated by
Voluntary: Firm initiated
Products in this event
1

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

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.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Mar 13, 2025. FDA classified it 34 days later, on Apr 16, 2025. Distribution reported by FDA: Nationwide in the USA Dr. Reddy's Laboratories, Inc. has 88 recalls in our records.

Recalled products (1)

  • D-0365-2025 Class I Ongoing

    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

    Codes / lots: Lot: A1540076, Exp 08/31/2026

    Quantity: 4,010 bags

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
Official notice
FDA Enforcement Report, event 96470
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.