# FDA recall D-0365-2025

> **Dr. Reddy's Laboratories, Inc.** · Class I · drug recall initiated 2025-03-13.

## 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

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0365-2025
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-13
- **Report date:** 2025-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0365-2025

## Citation

> AI Analytics. FDA recall D-0365-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0365-2025. Source: US FDA. Licensed CC0.

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