FDA Eye Care Product Recall: What You Need to Know

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Have you heard about the recent eye care product recall? If you use over-the-counter eye drops or related products, this recall affects you. The U.S. Food and Drug Administration (FDA) has issued a voluntary recall of several eye care products following a manufacturing audit. This is a crucial update that all consumers should be aware of, particularly those who rely on artificial tears and other eye solutions for dry and irritated eyes.

On May 12, 2025, the FDA reported that certain eye care products manufactured by AvKARE, a pharmaceutical distributor, were recalled due to manufacturing deviations. These deviations raised concerns about the quality of the products, and while the exact health risks associated with them remain unknown, the FDA cautioned consumers against using any affected items.

In total, the recall encompasses thousands of eye care products, including:

  • 13,872 cases of Artificial Tears Ophthalmic Solution (NDC: 50268-043-15)
  • 1,610 cases of Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC: 50268-066-15)
  • 32,876 cases of Carboxymethylcellulose Sodium Ophthalmic Solution (NDC: 50268-068-15)
  • 13,104 cases of Lubricant Eye Drops Solution (NDC: 50268-126-15)
  • 14,333 cases of Polyvinyl Alcohol Ophthalmic Solution (NDC: 50268-678-15)

The affected products were distributed between May 26, 2023, and April 21, 2025, with expiration dates ranging from April 2025 to March 2027. If you have purchased any of these products, it is crucial to take action immediately.

So, what should consumers do? The FDA advises anyone using the recalled products to stop using them immediately. AvKARE also has a straightforward procedure for refunds. If you own any of these products, you can complete a return form available on their website. Once completed, you are instructed to fax it to 931-292-6229 or email it to [email protected]. After submitting the form, AvKARE will send you a Return Authorization Form to facilitate the return of the products. They promise to issue a full credit for any returned items, including shipping costs.

For your safety and peace of mind, it is essential to stay informed about recalls that may impact products you use regularly. This latest recall serves as a reminder of the importance of vigilance in product safety, especially concerning health-related items.

Would you like to learn more about safe eye care practices? Or perhaps you're interested in discovering more products that prioritize quality and your wellness? Stay tuned for more updates and tips on maintaining healthy eyesight and proper eye care.

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