# FDA recall D-0495-2025

> **Apotex Corp.** · Class II · drug recall initiated 2025-05-28.

## Product

Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4

## Reason for recall

Lack of Assurance of Sterility

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0495-2025
- **Recalling firm:** Apotex Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-28
- **Report date:** 2025-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Weston, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0495-2025

## Citation

> AI Analytics. FDA recall D-0495-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0495-2025. Source: US FDA. Licensed CC0.

---

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