AvKARE has issued a voluntary nationwide recall of certain lots of eye drop products. This decision comes after an FDA inspection audit found that there were “manufacturing deviations.” In response, the company uploaded a notice of the recall on its website. It encouraged consumers to immediately stop using the impacted products. The recall affects products sent from May 26, 2023, to April 21, 2025. These products all have expiration dates ranging from April 2025 to March 2027.
The recall was prompted by the determination that during an FDA audit, it was discovered that there was objectionable contamination found on their products. AvKARE said that these “deviations can lead to products of intolerable quality.” In addition to supporting innovation, they emphasized, “We cannot ignore the possible risk to patients that may result from the introduction of these products.” Due to the risk of Listeria monocytogenes potentially contaminating the products, the company is withdrawing with caution to protect consumers.
Consumer Action Required
AvKARE is encouraging consumers who’ve bought the recalled eye drops to take immediate steps. They point consumers to the company’s website, where consumers can fill out a recall form. Once completed, consumers should either fax the filled-out form to 931-292-6229 or email it directly to customerservice@avkare.com.
AvKARE will send a Return Authorization Form directly to consumers. This is to enable them to return the recalled products after they fill out their recall-form submissions. This procedural change is designed to make shippers’ returns of potentially unsafe items a safe and convenient process.
Product Details and Support
The full list of affected products—with expiration dates and lot codes—is available on AvKARE’s website. Consumers can access the information directly as well, in part via a dedicated link on the FDA’s own website. AvKARE reiterates the importance of reviewing this information carefully. Taking these steps can ensure that you find out if your recently purchased eye drops are affected by the recall.
If you have questions about the recall, please contact AvKARE directly. If you have any questions, you can contact their customer service team at customerservice@avkare.com. The company has even agreed to safety precautions as consumers figured out how to return the products.
