Apotex Ketorolac Tromethamine Ophthalmic Solution Recall

Why it was recalled

Lack of Assurance of Sterility

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

Lot numbers, UPCs & expiration codes

Batch TZ1236, Exp Date: 11/30/2025

Where it was sold

US Nationwide.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0494-2025
Classification: Class II
Status: Ongoing
Recall initiated: May 28, 2025
FDA report date: Jul 2, 2025
Quantity: 87,840 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Apotex Corp.

Original FDA data

Every field from FDA enforcement report D-0494-2025, exactly as published.

Show all FDA fields

City: Weston
State: FL
Status: Ongoing
Country: United States
Event ID: 96954
Address: 2400 N Commerce Pkwy Ste 400
Code information: Batch TZ1236, Exp Date: 11/30/2025
Postal code: 33326-3253
Report date: Jul 2, 2025
Product type: Drugs
Recall number: D-0494-2025
Classification: Class II
Recalling firm: Apotex Corp.
Product quantity: 87,840 bottles
Reason for recall: Lack of Assurance of Sterility
Voluntary / mandated: Voluntary: Firm initiated
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
Distribution pattern: US Nationwide.
Recall initiation date: May 28, 2025
Initial firm notification: Letter
Center classification date: Jun 25, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0494-2025, published Jul 2, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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