Eye Care Products Recalled Over Manufacturing Concerns; Consumers Advised to Stop Use

A range of over-the-counter eye care products, including artificial tears and lubricating drops, have been voluntarily recalled following the discovery of manufacturing deviations during a US Food and Drug Administration (FDA) audit, according to a recent notice, USA Today reports.

The recall affects products distributed by pharmaceutical firm AvKARE and was initiated by the recalling company, BRS Analytical Services LLC. The reason for the recall, as outlined in the announcement, involves deviations in the manufacturing process that could result in products of substandard quality. While no specific health hazard has been confirmed, the possibility of risk to patients could not be ruled out, prompting the precautionary action.

The recalled eye care items were distributed between May 26, 2023, and April 21, 2025. According to the FDA’s notice and AvKARE’s press release, the affected products include:

• 13,104 cases of Lubricant Eye Drops Solution (NDC: 50268-126-15)

• 32,876 cases of Carboxymethylcellulose Sodium Ophthalmic Solution (NDC: 50268-068-15)

• 14,333 cases of Polyvinyl Alcohol Ophthalmic Solution (NDC: 50268-678-15)

• 1,610 cases of Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC: 50268-066-15)

• 13,872 cases of Artificial Tears Ophthalmic Solution (NDC: 50268-043-15)

Consumers in possession of any of the recalled items are being urged to discontinue their use immediately. The FDA is aware of the recall, although no reports of adverse health outcomes have been confirmed as of now.

Buyers and distributors holding affected inventory are encouraged to return the products. A “Quality to Return” form, available in the recall notice, should be completed and sent by fax to 931-292-6229 or emailed to [email protected].

Once the form is submitted, AvKARE will provide a “Return to Authorization Form” along with instructions for returning the recalled items. Customers will receive full credit for the returned products, including reimbursement for shipping costs.

Consumers who experience any adverse effects from these products are advised to seek medical attention and report the incident to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

As of now, AvKARE has not issued a public statement with further details.