FDA warning: These popular eye drops could be dangerous. What do I do if I have one of the contaminated lots?

In 2023, the US Food and Drug Administration (FDA) warned the public about the dangers certain brands of eye drops posed to their health after an investigation found that contaminants within the drops could lead to infection. Two years later, the risk from some of these brands persists.

AVKare, a pharmaceutical distributor, released a statement announcing that BRS Analytical Services had issued a voluntary recall after an FDA audit. The recall covers a variety of eye-related drugs, including artificial tears and eye drops.

The FDA has yet to publish any information on the recall, which could make it hard for consumers to know if they purchased products that fall under the health advisory. When navigating the FDA’s National Drug Code (NDC) Directory, consumers can search for the drugs covered under the recall. However, the directory does not provide any information on where the products were sold.

Which products are covered by the recall?

These are the products covered by the recall, ordered by their National Drug Code (NDC) number:

The distributor has provided the affected products’ lot numbers and expiration dates. Be sure to visit the webpage for that information as you evaluate whether or not you purchased one of these products.

Where on your medication can you find the NDC?

The packaging and bottle of your over-the-counter medication should contain the NDC in an easy-to-spot location. Unlike the batch number, which changes, the NDC remains constant, so long as there are no changes to the medication.

Be sure to check the front of the package near the top, or on the Drug Facts, near the bottom of the list, where the batch number should be located. To verify if your product has been recalled, you must refer to the lot number and expiration date, which should be found in the Drug Facts area of the packaging.

What you should do if you purchased a product covered by the recall

If you have purchased any of the products listed above between May 26, 2023, and April 21, 2025, you might have a defective product on your hands. If so, you should email or fax the “Quantity to Return” form provided by AVKare. The company urges those who don’t have a quantity to return, but purchased one of these products to fill out and submit the form too.

“This recall is being carried out with the knowledge of the US Food and Drug Administration,“ reported AVKare, adding that ”further use of this product should immediately cease.”

Upon receiving your Quantity to Return form, AVKare says they “will send you a Return Authorization Form (RA).” You will then need to send any of the recalled products in your possession to:

The directions provided by the distributor say that the “copy of the letter,” presumably the one sent by the company, should be included in the package and that it should be labeled ”Ophthalmic RECALL."

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