The freedom to choose safe over-the-counter medications now faces another threat as a recent FDA audit forces AvKARE to announce a substantial recall.
See the tweet below!
This precautionary measure affects multiple eye drop products, yet specific health risks remain unknown.
A voluntary recall has been issued for several popular over-the-counter eye products following an audit by the U.S. Food and Drug Administration (FDA).
AvKARE, the distributor of the affected products, acknowledged significant manufacturing deviations discovered during the audit.
These deviations resulted in the withdrawal of these products as a precautionary step even as specific health risks remain unknown.
AvKARE’s recall primarily concerns various eye drops, including 13,872 cases of Artificial Tears Ophthalmic Solution and 1,610 cases of Carboxymethylcellulose Sodium Ophthalmic Gel 1%.
Additional recalled products include 32,876 cases of Carboxymethylcellulose Sodium Ophthalmic Solution, 13,104 cases of Lubricant Eye Drops Solution, and 14,333 cases of Polyvinyl Alcohol Ophthalmic Solution.
These products were distributed nationwide between May 26, 2023, and April 21, 2025, with expiration dates extending from April 2025 to March 2027.
While no direct health threats have been confirmed, AvKARE states that “deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.”
Consequently, consumers are urged to stop using these products immediately and consult health care professionals regarding alternatives.
AvKARE has extended measures to ensure customers are not financially burdened by the recall.
Consumers who purchased recalled products can expect a full refund, including shipping costs, upon returning the items.
Instructions for returns are provided on AvKARE’s website, requiring a recall form to be completed and submitted via fax or email to obtain a Return Authorization Form.
Retailers and distributors are also advised to check their stocks and ensure none of the recalled eye drops remain actively distributed or sold.
AvKARE emphasizes this recall’s precautionary nature while continuing efforts to address the found deviations seriously.
Distributor AvKARE was notified of the drug recall by the recalling firm, BRS Analytical Services LLC. https://t.co/2SuDbIfzMf
— Las Cruces Sun-News (@CrucesSunNews) May 12, 2025
