Reported Mar 20, 2024 · Terminated

Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA…

Thea Pharma, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Thea Pharma, Inc. · 303 Wyman St · Waltham, MA · 02451-1208

Is this the product you have?

    • Betimol (timolol ophthalmic solution) 0.5%
    • 15mL bottles
    • Rx only
  • Manufactured for
    • Thea Pharma Inc. Lexington
    • MA 02420
    • NDC 82584-002-15
Lot codes and dates
    • Lot #: 435019
    • Exp. Date 11/2024
Amount recalled
5,476 bottles

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 30, 2025 · Data as of Sep 19, 6:37 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.