Recalls / Class I
Class ID-0365-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Brand name
- Levetiracetam
- Generic name
- Levetiracetam Injection
- Active ingredient
- Levetiracetam
- Route
- Intravenous
- NDCs
- 43598-635, 43598-636, 43598-637
- FDA application
- ANDA206880
- Affected lot / code info
- Lot: A1540076, Exp 08/31/2026
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.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Inc
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 4,010 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-03-13
- FDA classified
- 2025-04-16
- Posted by FDA
- 2025-04-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0365-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.