FDA Drugs recall ·
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only… recall
- Recall number
- D-0494-2025
- Date
- (initiated May 28, 2025)
- Company / brand
- Apotex Corp.
2400 N Commerce Pkwy Ste 400, Weston, FL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 87,840 bottles
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2
Why was it recalled?
Lack of Assurance of Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch TZ1236, Exp Date: 11/30/2025
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0494-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.