# FDA recall D-0924-2023

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2023-07-05.

## Product

Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.

## Reason for recall

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

## Distribution

USA nationwide.

## Key facts

- **Recall number:** D-0924-2023
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-07-05
- **Report date:** 2023-07-26
- **Termination date:** 2024-02-26

- **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-0924-2023

## Citation

> AI Analytics. FDA recall D-0924-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0924-2023. Source: US FDA. Licensed CC0.

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