BRS Analytical, AvKARE Recall 1.8 Million Eye Drop Cartons in US, France Over Sterility, Alcohol Traces
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BRS Analytical Service, LLC has issued a voluntary recall of several over-the-counter ophthalmic products, including artificial tears and various eye drops, following manufacturing deviations identified during a U.S. Food and Drug Administration (FDA) audit.
The recall affects five products: 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). More than 1.8 million cartons, totaling over 75,000 cases, were distributed nationwide in the United States between May 26, 2023, and April 21, 2025. AvKARE is the distributor for these products.
The manufacturing deviations include a lack of assurance of sterility and, for some physiological saline solutions in Europe, possible traces of cleaning alcohol due to insufficient cleaning documentation at production sites. The affected brands in France include Ainsifont (44 lots), GSL (22 lots), Happylab (41 lots 1L, 27 lots 500ml), Mediphysio (20 lots), and Stentil (11 lots), with nearly 150 lots recalled.
The health risks associated with the recalled products are currently unknown, but the deviations may lead to products of unacceptable quality, and patient risks cannot be ruled out. The FDA has classified the recall as Class II, indicating a situation where use of the product may cause reversible adverse health consequences or where the probability of serious health consequences is remote.
Consumers are advised to immediately discontinue use of the recalled products and either dispose of them or return them to the place of purchase for a full refund. Detailed instructions for returns are available through AvKARE and the FDA websites.
