FDA Drugs recall ·
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0365-2025
- Date
- (initiated March 13, 2025)
- Company / brand
- Dr. Reddy's Laboratories, Inc.
107 College Rd E, Princeton, NJ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 4,010 bags
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: A1540076, Exp 08/31/2026
Distribution
Nationwide in the USA
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0365-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.