FlaggedRx← Medication recall checkHome
Class I · Most seriousActive recall

Levetiracetam

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot: A1540076, Exp 08/31/2026
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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 to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 foreign manufacturer
Brand nameLEVETIRACETAM
Generic nameLEVETIRACETAM INJECTION
Active ingredient(s)LEVETIRACETAM
Distributed by / forDr. Reddy's Laboratories, Inc.
NDC43598-636-52
Show the full FDA record
Full product labelLevetiracetam 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
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionNationwide in the USA
Quantity4,010 bags
Recall initiated2025-03-13
Report date2025-04-23
Recall completed—
Recall numberD-0365-2025
ClassificationClass I
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.