Apotex Ketorolac Ophthalmic Solution Recall: Lack of Sterility Assurance
Apotex recalls Ketorolac 0.5% eye drops due to lack of sterility assurance. This could cause infections. Check NDC 60505-1003-2, batch TZ1236, exp 11/30/2025.
Recall notice
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
Apotex is recalling Ketorolac Tromethamine Ophthalmic Solution 0.5% 10mL eye drops because they may not be sterile. This could lead to eye infections if used. The recall applies to prescription-only products with specific batch and expiration details. Read more at govinfonow.com/recall/32045-apotex-ketorolac-ophthalmic-solution-recall-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/32045-apotex-ketorolac-ophthalmic-solution-recall-lack-of-sterility-assurance · Updated August 17, 2026 · FDA enforcement record: FDA #D-0494-2025
Cite this page
“Apotex Ketorolac Ophthalmic Solution Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32045-apotex-ketorolac-ophthalmic-solution-recall-lack-of-sterility-assurance. Based on FDA recall #D-0494-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0494-2025%22&limit=1).
Why it’s dangerous
The product may not be sterile, which can lead to eye infections. This is a serious risk for people using the medication as prescribed.
Who’s affected
Prescription users of Ketorolac eye drops with the specific NDC 60505-1003-2 and batch TZ1236. People with eye conditions requiring this medication are most at risk.
How to tell if you have this one
Check for the NDC code 60505-1003-2 and batch number TZ1236 on the label. The expiration date is November 30, 2025. This product is prescription-only.
- Brand
Apotex- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0494-2025 | 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; Batch TZ1236, Exp Date: 11/30/2025 | 87,840 bottles | 60505-1003-1, 60505-1003-2 |
| D-0495-2025 | 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; Batch VD1654, Exp Date: 06/30/2027 | 105,456 Bottles | 60505-0578-4 |
| D-0496-2025 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3; Batch VC6058, Exp Date: 10/31/2025 | 6,288 Bottles | 60505-0589-1, 60505-0589-2, 60505-0589-3 |
What to do — step by step
Check Product Details
Look for NDC 60505-1003-2 and batch TZ1236 on the label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall states there is a lack of sterility assurance, so it may not be safe. Do not use until you confirm it's not recalled.
Similar recalls
Other Apotex recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0494-2025 (May 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0494-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.