Class II U.S. Food and Drug Administration

Apotex Corp. Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL recall: Lack of Assurance of Sterility; atypical weight loss due to improper bottle

Recall published 1+ years ago

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

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0677-2025
Published
October 8, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Apotex Corp.
Product type
Prescription & OTC drugs
Units affected
493,468 bottles
Distribution
Nationwide
Made in
United States
Lot / 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
UPC codes
360505100316

Products covered by this recall

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.

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 360505100316

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • VA0444
  • 2026 Batch # VA4608
  • 2026 Batch # TZ7

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 01
  • 2026 Batch # VA4608
  • 2026
  • 12

NDC number

On the carton and again on the bottle or blister label.

  • 60505-1003-1

Package size

Match the net weight or the piece count on the front of the pack.

  • 5 mL

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Apotex Corp. — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  3. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  4. Report any infection or reaction you think the product caused to FDA MedWatch.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Apotex Corp. — 2400 N Commerce Pkwy Ste 400, Weston, FL, 33326-3253

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Apotex Corp. prescription & otc drugs recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 360505100316; lot code VA0444, 2026 Batch # VA4608, 2026 Batch # TZ7; best-by date 01 or 2026 Batch # VA4608. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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