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Drug FDA Class II Ongoing Contamination / non-sterility

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.

Apotex Corp. Published Oct 8, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Apotex Corp. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Hazards

Lack of Assurance of Sterility · primary

Affected products (1)

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.

KETOROLAC TROMETHAMINE · 493,468 bottles

NDC: 60505-1003, 60505-1003-1, 60505-1003-2, 6050510031, 3605051003
Code info: 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

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 5, 2025
  2. Published
    Oct 8, 2025
Recall number
D-0677-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.