Over 75,000 cases of eye drop solutions have been voluntarily recalled nationwide by BRS Analytical Service, a pharmaceutical testing lab, as reported by the Food and Drug Administration. The recall was initiated by AvKare, a manufacturer of medical and pharmaceutical products. This action followed an FDA audit at BRS Analytical Service that identified deviations from Current Good Manufacturing Practices (cGMP). These deviations could compromise product quality and pose potential risks to patients. The recall is specifically due to a lack of assurance regarding sterility in the affected products, which include artificial tears and eye lubricants designed to relieve dryness and irritation.
The recall covers ophthalmic solutions shipped between May 26, 2023, and April 21, 2025. Consumers are advised to stop using the following products immediately: Artificial Tears Ophthalmic Solution (NDC# 50268-043-15), Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC# 50268-066-15), Carboxymethylcellulose Sodium Ophthalmic Solution (NDC# 50268-068-15), Lubricant Eye Drops Solution (NDC# 50268-126-15), and Polyvinyl Alcohol Ophthalmic Solution (NDC# 50268-678-15). Consumers with these products are encouraged to complete a Recall Form and email it to AvKare for further instructions. Full credit, including shipping costs, will be provided upon return.
For those affected, expert-recommended alternatives include warm compresses, humidifiers, and specialized eyelid cleansers. Dr. Yuna Rapaport, a board-certified ophthalmologist, suggests using a humidifier to alleviate evaporative dry eye and cleansing eyelids with products like Ocusoft pads or Eye Revive by Daily Practice.
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