# FDA recall D-0133-2024

> **Cardinal Health Inc.** · Class I · drug recall initiated 2023-10-31.

## Product

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1

## Reason for recall

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0133-2024
- **Recalling firm:** Cardinal Health Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-10-31
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0133-2024

## Citation

> AI Analytics. FDA recall D-0133-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0133-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*