Ketorolac ophthalmic solution recalled over sterility assurance and bottle sealing concerns
Apotex is recalling 493,468 bottles of Ketorolac Tromethamine Ophthalmic Solution 0.5% because atypical weight loss from improper bottle sealing raises sterility concerns.
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: Scored 3 under the risk-of-harm criterion: a loss of sterility assurance in a sterile ophthalmic product creates an infection risk, and no injuries are reported.
Plain-English summary
Ketorolac Tromethamine Ophthalmic Solution 0.5%, 5 mL, prescription only, manufactured by Apotex Inc. of Richmond Hill, Ontario for Apotex Corp. of Weston, Florida, is being recalled for lack of assurance of sterility. The recall notice attributes this to atypical weight loss caused by improper bottle sealing, which leads to potential sterility concerns.
The recall covers 493,468 bottles carrying NDC 60505-1003-1, from batch VA0444 expiring 01/2026, batch VA4608 expiring 01/2026 and batch TZ7016 expiring 12/2025. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
Sterility matters for an eye drop because the product is applied directly to the ocular surface. The enforcement record describes a loss of sterility assurance rather than confirmed contamination, and reports no injuries.
Patients holding the listed batch numbers should contact their pharmacy or prescriber about a replacement rather than continuing to use the product.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Ophthalmic solution
- Affected units
- 493,468
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 (3)
- Batch # VA0444
- exp. date 01/2026 Batch # VA4608
- exp. date 01/2026 Batch # TZ7016
UPCs (1)
- 360505100316
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
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