# FDA recall D-0162-2023

> **MACLEODS PHARMA USA, INC** · Class III · drug recall initiated 2023-01-05.

## Product

Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08

## Reason for recall

Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

## Distribution

Nationwide within United States and Puerto Rico.

## Key facts

- **Recall number:** D-0162-2023
- **Recalling firm:** MACLEODS PHARMA USA, INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-01-05
- **Report date:** 2023-01-25
- **Termination date:** 2025-06-24

- **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-0162-2023

## Citation

> AI Analytics. FDA recall D-0162-2023. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/D-0162-2023. Source: US FDA. Licensed CC0.

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