# FDA recall D-0677-2025

> **Apotex Corp.** · Class II · drug recall initiated 2025-09-05.

## Product

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.

## Reason for recall

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0677-2025
- **Recalling firm:** Apotex Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-09-05
- **Report date:** 2025-10-08

- **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-0677-2025

## Citation

> AI Analytics. FDA recall D-0677-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0677-2025. Source: US FDA. Licensed CC0.

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