Eye Care Product Recall From Trusted Distributor Includes 1000s of Cases
A sweeping voluntary recall has been issued for over-the-counter eye care products—including artificial tears and other ophthalmic solutions—after a U.S. Food and Drug Administration (FDA) audit uncovered a manufacturing deviation that may pose a health risk to consumers.
Pharmaceutical distributor AvKARE was alerted by BRS Analytical Services LLC, the recalling firm, that several batches of eye care products may be of "unacceptable quality." While specific health hazards remain unknown, officials say the potential risk to patients cannot be ruled out. The FDA is reportedly aware of the recall.
Consumers are urged to stop using the recalled products immediately and follow the return procedures outlined in AvKARE's recall notice. Affected items were distributed between May 26, 2023, and April 21, 2025, and include:
- 13,104 cases of Lubricant Eye Drops Solution
- 32,876 cases of Carboxymethylcellulose Sodium Ophthalmic Solution
- 14,333 cases of Polyvinyl Alcohol Ophthalmic Solution
- 1,610 cases of Carboxymethylcellulose Sodium Ophthalmic Gel 1%
- 13,872 cases of Artificial Tears Ophthalmic Solution
Each of these products is identified by its national drug code (NDC), available on the FDA’s recall website and AvKARE’s press release. Consumers, retailers, and healthcare providers who may have inventory of the affected products should complete the "Quality to Return" form provided in the recall notice and send it to AvKARE via fax or email. Upon confirmation, customers will receive return instructions and a full refund, including shipping.
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The recall follows other recent product withdrawals related to quality control issues, underscoring the importance of FDA oversight in consumer health products, especially everyday essentials like eyecare products.