Ketorolac Tromethamine Solution/ Drops
FDA Recall NDC 60505-1003
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Ketorolac Tromethamine (NDC 60505-1003). A significant event, classified as Class II, was initiated on Sep 05, 2025 by Apotex Corp.. The reported reason for this action was: "Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
September 2025 Class II Recall: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Recall Number
Class II Ongoing
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Sep 05, 2025
Oct 08, 2025
493,468 bottles
Recall Profile & Regulatory Data
Event ID
97561
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
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.
Batch or Lot Expiration Information
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 Packages Involved in this Recall
60505-1003-1Product
60505-1003-2Product
6050510031Product
3605051003Product
Class II Ongoing
Lack of Assurance of Sterility
May 28, 2025
Jul 02, 2025
87,840 bottles
Recall Profile & Regulatory Data
Event ID
96954
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
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
Batch or Lot Expiration Information
Batch# Batch TZ1236, Exp Date: 11/30/2025
Affected Packages Involved in this Recall
60505-1003-1Product
60505-1003-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
