Reported Jan 4, 2023 · Terminated

Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg…

Apotex Corp.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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?

  • Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only
  • Mfg byApotex Inc. Toronto
  • Ontario Canada M9L 1T9 Mfg for
    • Apotex Corp. Weston
    • FL 33326
    • NDC 60505-1005-4
Lot codes and dates
    • Lot# TA4844
    • Exp 03/2023
Amount recalled
22,027 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 8, 2025 · Data as of Sep 19, 7:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.