Ketorolac Tromethamine Ophthalmic Solution recall
FDA recall D-0677-2025 · initiated Sep 5, 2025
Apotex Corp. recalled Ketorolac Tromethamine Ophthalmic Solution in Sep 2025 — an FDA Class II recall (D-0677-2025) because Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 493,468 bottles
Details
- Product
- Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.
- Recalling company
- Apotex
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Sep 5, 2025
- FDA report date
- Oct 8, 2025
Frequently asked
- Was Ketorolac Tromethamine Ophthalmic Solution recalled?
- Apotex Corp. recalled Ketorolac Tromethamine Ophthalmic Solution in Sep 2025 — an FDA Class II recall (D-0677-2025) because Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Ketorolac Tromethamine Ophthalmic Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0677-2025 was: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
- Is a recalled Ketorolac Tromethamine Ophthalmic Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ketorolac Tromethamine Ophthalmic Solution are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Batch # VA0444, exp. date 01/2026 Batch # VA4608, exp. date 01/2026 Batch # TZ7016, exp. date 12/2025 UPC on Bottles: (01)0(03)60505100316 UPC on Cartons: 360505100316. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0677-2025.