Reported Oct 8, 2025 · Ongoing
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill,…
Apotex Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apotex Corp. · 2400 N Commerce Pkwy Ste 400 · Weston, FL · 33326-3253
Is this the product you have?
- Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile
- Manufactured byApotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2
- Manufactured forApotex Corp., Weston, FL 33326, NDC 60505-1003-1
- Lot codes and dates
Batch # VA0444exp. date 01/2026 Batch # VA4608exp. date 01/2026 Batch # TZ7016exp
- date 12/2025 UPC on Bottles(01)0(03)60505100316
- UPC on Cartons360505100316
- Amount recalled
- 493,468 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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