Voluntary recall issued for eye drops sold nationwide
Several over-the-counter eye products used to treat dry and irritated eyes have been voluntarily recalled following an audit by the U.S. Food and Drug Administration.
AvKARE, a pharmaceutical distributor, issued a voluntary recall notice on its website, noting that the products are being recalled due to "manufacturing deviations" found during the FDA audit.
According to the recall notice, the exact health dangers for consumers using the recalled products are unknown, but the company said "deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products."
ABC News has reached out to AvKARE for further information.
Here is what to know about the products being recalled and what consumers can do.
What products are being recalled?
Both the FDA and AvKARE have detailed information on their websites about the products being voluntarily recalled.
The FDA's website also lists the number of cases involved in the recall:
- 13,872 cases of Artificial Tears Ophthalmic Solution (National Drug Code: 50268-043-15)
- 1,610 cases of Carboxymethylcellulose Sodium Ophthalmic Gel 1% (National Drug Code: 50268-066-15)
- 32,876 cases of Carboxymethylcellulose Sodium Ophthalmic Solution (National Drug Code: 50268-068-15)
- 13,104 cases of Lubricant Eye Drops Solution (National Drug Code: 50268-126-15)
- 14,333 cases of Polyvinyl Alcohol Ophthalmic Solution (National Drug Code: 50268-678-15)
When were the products distributed?
The recalled items were first shipped between May 26, 2023, and April 21, 2025, according to AvKARE.
Expiration dates range from April 2025 to March 2027. Click here or here for a full list of expiration dates, lot codes and other product details.
What should consumers do?
AvKARE is advising consumers to discontinue use of the recalled products immediately.
Are consumers able to get a refund?
Yes, according to AvKARE.
The company is asking consumers to fill out a recall form on its website and fax the completed form to 931-292-6229 or email it to customerservice@avkare.com.
Once the form is received, the company will send consumers a Return Authorization Form to ship the product back to AvKARE.
The company says it will issue full credit, including shipping cost, for any returns.
