Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Brimonidine Tartrate Opthalmic Solution 0.2% Recalled by SOMERSET THERAPEUTICS LLC Due to Failed Impurities/Degradation Specification: There is a slow leaching...

Date: June 4, 2020
Company: SOMERSET THERAPEUTICS LLC
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 SOMERSET THERAPEUTICS LLC directly.

Affected Products

Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01

Quantity: 22,788 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SOMERSET THERAPEUTICS LLC

SOMERSET THERAPEUTICS LLC has 8 total recalls tracked by RecallDetector.

Related Recalls

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