75,000+ Eye Care Products Recalled Nationwide; Consumers Advised to Stop Using ‘Immediately’
Key Takeaways
- Over 75,000+ cases of eye care products were recalled due to safety concerns from manufacturers.
- Over-the-counter ophthalmic products were voluntarily recalled due to manufacturing deviations found during a U.S. Food and Drug Administration audit.
If you use eye drops, stop what you’re doing and check your medicine cabinet. Over 75,000 cases of eye products were recalled due to a potential safety risk that the U.S. Food and Drug Administration discovered during an audit. BRS Analytical Services LLC, the recalling firm, alerted the Pharmaceutical distributor AvKARE to the drug recall, according to USA Today. Several products were discovered to have manufacturing deviations that “may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.”
The FDA issued a Class II risk, the second-highest warning rating, to five ophthalmic solutions, including:
- 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
What would happen if you used the contaminated eye products?
The FDA has defined a Class II risk as “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” While no specific health consequences were mentioned in the recall, consumers are urged not to use any eye products related to the recall.
When were the products shipped?
According to a statement issued by AvKARE, the affected cases of eye care products were first shipped on May 26, 2023, through April 21, 2025.
For further details, such as expiration dates and lot codes, click here or here.
What should customers do if they have any recalled products in their homes?
If you check your medicine cabinet and find the recalled eye products, don’t panic. Visit https://www.avkare.com/recall and download a PDF copy of the recall notice to fill in and fax back to AvKARE. They advise consumers to complete the “Quantity to Return” section and the Customer information block, then fax the completed form to 931-292-6229 or email [email protected]. Once AvKARE receives your form, they’ll send back a Return Authorization Form (RA).
Customers are also advised to return any recalled products to the following address:
R&S Northeast LLC
8407 Austin Tracy Rd
Fountain Run, KY 42133
AvKARE promises to issue full credit, including shipping costs, on returns.
Cover Image Credit: RUBEN BONILLA GONZALO / Getty Images
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Originally published May 13, 2025
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