# FDA recall D-0502-2024

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2024-04-22.

## Product

Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90

## Reason for recall

Failed Release Testing: Out of specification for particulate matter test.

## Distribution

TX, PA

## Key facts

- **Recall number:** D-0502-2024
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-04-22
- **Report date:** 2024-05-29

- **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-0502-2024

## Citation

> AI Analytics. FDA recall D-0502-2024. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0502-2024. Source: US FDA. Licensed CC0.

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