Ketorolac Tromethamine Ophthalmic Solution Recalled for Sterility Assurance Issues
Apotex Corp. is recalling 87,840 bottles of Ketorolac Tromethamine Ophthalmic Solution due to lack of sterility assurance. The prescription eye drop was distributed nationwide with batch TZ1236 expiring 11/30/2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (sterile ophthalmic solution) where lack of sterility assurance represents potential contamination. No illnesses or injuries are reported in the source. The FDA Class II classification with this theoretical hazard results in a High severity rating per the rubric.
Plain-English summary
Apotex Corp. is recalling Ketorolac Tromethamine Ophthalmic Solution 0.5%, 10 mL, Rx Only due to lack of assurance of sterility. Approximately 87,840 bottles have been distributed nationwide. The recalled batch is TZ1236 with an expiration date of 11/30/2025.
Ketorolac Tromethamine is a prescription eye drop used to reduce pain and inflammation. The manufacturer cannot assure that the product meets required sterility standards for pharmaceutical ophthalmic products.
Consumers in possession of this product should stop using it and contact their healthcare provider for an alternative. Healthcare providers and pharmacies should check their inventory for batch TZ1236 and remove the affected product from dispensing.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Ophthalmic / Eye Drop
- Hazard
- sterility-failure
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch TZ1236
- Exp Date: 11/30/2025
Distribution
Distributed nationwide across the United States.
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