AvKARE, a pharmaceutical distributor, has issued a voluntary recall for several over-the-counter eye products used to treat dry and irritated eyes after a U.S. Food and Drug Administration audit identified “manufacturing deviations,” the company announced.
The recall, detailed on AvKARE’s website, affects multiple products, including:
- 13,872 cases of Artificial Tears (National Drug Code: 50268-043-15)
- 1,610 cases of Carboxymethylcellulose Gel (50268-066-15)
- 32,876 cases of Carboxymethylcellulose Solution (50268-068-15)
- 13,104 cases of Lubricant Eye Drops (50268-126-15)
- 14,333 cases of Polyvinyl Alcohol Solution (50268-678-15)
According to AvKARE, the products were distributed nationwide between May 26, 2023, and April 21, 2025, with expiration dates ranging from April 2025 to March 2027. A full list of lot codes, expiration dates, and product details is available on AvKARE’s and the FDA’s websites.
The recall notice states that the “deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.” The exact health dangers remain unknown, and ABC News has reached out to AvKARE for further clarification.
AvKARE advises consumers to stop using the recalled products immediately. The company is offering full refunds, including shipping costs, for returned items. Consumers are instructed to complete a recall form on AvKARE’s website and submit it via fax to 931-292-6229 or email to [email protected]. Upon receipt, AvKARE will provide a Return Authorization Form for shipping the products back.
For additional information, consumers can visit AvKARE’s or the FDA’s websites.