FDA Recall D-0365-2025

Dr. Reddy's Laboratories, Inc. · Princeton, NJ

Class I — life-threatening Ongoing 427 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

Lot / code: Lot: A1540076, Exp 08/31/2026

Quantity: 4,010 bags

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.

Recall record

Recall number: D-0365-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Recall initiated: 2025-03-13
Classified by FDA Center: 2025-04-16
FDA published: 2025-04-23
Recalling firm: Dr. Reddy's Laboratories, Inc.
Firm location: Princeton, NJ

Drug identification

Brand name(s): LEVETIRACETAM
Generic name(s): LEVETIRACETAM INJECTION
Manufacturer(s): Dr.Reddy's Laboratories Inc
NDC(s): 43598-635, 43598-636, 43598-637
Route(s): INTRAVENOUS

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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