More than 1.8 million eye drop bottles distributed nationwide are being recalled because the products may not be sterile.
AvKARE issued the voluntary recall for 1,819,080 cartons of eye drops in 75,795 cases. The Tennessee company said an audit by the Food and Drug Administration found manufacturing violations at BRS Analytical Services, the firm responsible for producing the eye care products.
The drops were sold under AvKARE’s label and shipped between Friday, May 26, 2023, and Monday, April 21, 2025. The FDA classified this as a “Class II” recall, which means using the products may cause temporary or medically reversible health consequences.
The recall affects the following products:
- 332,928 cartons of artificial tears ophthalmic solution
- 38,640 cartons of carboxymethylcellulose sodium ophthalmic gel 1%
- 789,024 cartons of carboxymethylcellulose sodium ophthalmic solution 0.5%
- 314,496 cartons of lubricant eye drops solution
- 343,992 cartons of polyvinyl alcohol ophthalmic solution
The company emphasized that these issues could lead to contaminated products of “unacceptable quality,” potentially creating risks for users.
If you or a loved one has suffered losses due to these, or any AvKARE product, you may be entitled to compensation. To learn more, contact the trusted product liability attorneys at Breslin and Breslin.
