New York residents as well as citizens across the United States are being made aware of a massive recall of a variety of over-the-counter eye care drops and artificial tears issued due to an issue discovered by the U.S. Food and Drug Administration. The recall applies to tens of thousands of cases of over-the-counter ophthalmic products that were shipped across the country over the last two years.

Nationwide Eye Drop Recall

Starting with the basics, the recall was issued by AvKARE - HealthKARE Solutions for Tomorrow, a company that distributes a variety of pharmaceuticals, medical & surgical items, as well as healthcare equipment.

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According to an article from the USA Today and others, a recent audit was conducted by the U.S. Food and Drug Administration and it was during the audit that they discovered what was called a "manufacturing deviation". This deviation in the manufacturing process "...may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products".

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Following the discovery, a recall was issued to the consumer level for all the implicated products of which there are several. The named products in the recall were as follows...

  • NDC# 50268-043-15 Artificial Tears Ophthalmic Solution
  • NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
  • NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution
  • NDC# 50268-126-15 Lubricant Eye Drops Solution
  • NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution
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The products affected by the recall were distributed to stores across the country between May 26, 2023, until April 21, 2025. According to the FDA, the recall applies to nearly 76,000 total cases of the distributed eye care products. FDA data also shows that  each case holds 24 cartons of the effected products. That's approximately 1.8 million cartons.

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In their own press release, AvKARE also issued a variety of charts that show buyers of how exactly to identify and determine if they purchased any of the tainted eye care products. That press release and associated charts can be found in the "recall was issued" link, located above. The effected products can be identified via their expiration dates, as well as their lot number or their National Drug Code (NDC).

What Should Consumers Do?

As is the case with any recall of any product, those who purchased the effected goods are also given an option for what to do in the aftermath. In this case AvKARE in their press release also requested that buyers who still have items in their inventory download a PDF copy of their "Quality to Return" form and fill out the required information.

That form and PDF copy can be found in the press release linked further above. When the form has been filled out, fax it to 931-292-6229 or email it to customerservice@avkare.com.

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Once completed, AvKARE will send a Return Authorization Form (RA). When returning the product(s), include a copy of your letter in your return package and mark the shipping container: Ophthalmic RECALL. The return should also be addressed to R&S Northeast LLC8407 Austin Tracy RdFountain Run, KY 42133.

When done with the required steps, full credit including shipping cost for any returns will be issued. You may also contact AvKARE with any further questions regarding the recall.

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