Additional Coverage:
- Eye care products recalled nationwide as customers warned to stop use ‘immediately’ (the-independent.com)
Eye Drop Recall Affects Nearly Two Million Cartons
A major eye drop recall is underway, affecting almost two million cartons distributed nationwide. BRS Analytical Service, LLC, the manufacturer, initiated the recall of five different eye care solutions after an FDA audit revealed violations of Current Good Manufacturing Practice (CGMP) regulations. These regulations ensure the quality and safety of drug manufacturing processes.
The recalled solutions include Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution, and Polyvinyl Alcohol Ophthalmic Solution. While the specific health risks are not yet confirmed, the FDA cited a “lack of assurance of sterility” as a reason for the recall. Deviations from CGMP standards raise concerns about the overall quality of the products and the potential for patient risk.
The affected eye drops were shipped between May 26, 2023, and April 21, 2025. Consumers are urged to immediately discontinue use and either discard the products or return them to the point of purchase for a full refund.
AvKARE, the distributor, is requesting consumers to fill out a recall notice, even if they no longer possess the recalled eye drops. This information will assist the company in assessing the scope of the recall.
This recall is classified as a Class II recall by the FDA, indicating a reasonable probability of serious adverse health consequences or death if the contaminated product is used. This incident follows other recent recalls, including Optimal Carnivore’s Bone & Joint Restore capsules due to potential salmonella contamination and Henkel’s Tec Italy Totale Shampoo due to possible Klebsiella oxytoca bacteria contamination.
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- Eye care products recalled nationwide as customers warned to stop use ‘immediately’ (the-independent.com)