Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Betimol (timolol ophthalmic solution) 0.5% Recalled by Thea Pharma, Inc. Due to Lack of Assurance of Sterility: Out of specification...

Date: March 5, 2024
Company: Thea Pharma, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Thea Pharma, Inc. directly.

Affected Products

Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15

Quantity: 5,476 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Thea Pharma, Inc.

Thea Pharma, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report