Ketorolac Tromethamine Ophthalmic Solution Recalled for Sterility Risk
Apotex Corp. is recalling Ketorolac Tromethamine Ophthalmic Solution 0.5% due to lack of assurance of sterility. The recall affects 87,840 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall as stated by the agency. Lack of sterility assurance in an ophthalmic drug product presents a significant risk of adverse health consequences, including infection. Class II recalls with such risk warrant a Severe classification.
Plain-English summary
Apotex Corp. is recalling Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL (NDC 60505-1003-2) due to lack of assurance of sterility. The recalled product was manufactured by Apotex Inc. in Toronto, Ontario, Canada, and manufactured for Apotex Corp. in Weston, Florida. The recall involves 87,840 bottles distributed nationwide in the United States.
The affected batch is TZ1236 with an expiration date of November 30, 2025. Ketorolac Tromethamine is a prescription ophthalmic (eye) medication.
Patients who have received this product should contact their healthcare provider or pharmacist. Distributors and healthcare facilities should stop dispensing the recalled product and return it to the manufacturer.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Apotex Corp.
- Affected units
- 87,840
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.
Part of a larger recall action
This product is one of 3 recalled by Apotex Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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