Class II · Moderate risk
Dexamethasone Moxifloxacin Ketorolac
Presence of particulate matter - Glass like particles.
Ketorolac Tromethamine Ophthalmic Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Affected NDC
60505-1003-02
Compare with the code on your package — it is the most precise check available.
Drug: Ketorolac Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Ketorolac Tromethamine NDC 60505-1003 |
5 mg/mL | Solution/ Drops Ophthalmic |
Apotex Corp. | Rx |
- Recalling firm
- Apotex Corp.
- NDC code
- 60505-1003-2
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0494-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Ketorolac recalls
See all
Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
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R.E.C.K.
Presence of Particulate Matter
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter: Particulate matter identified as glass
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Other recalls by Apotex Corp.
All 2025 recalls
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Class II · Moderate risk
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Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Lack of Assurance of Sterility
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
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