15.05.2025.
In an important health and safety notice, U.S.-based company BRS Analytical Service, LLC has issued a voluntary recall of five types of eye care products, following an inspection by the U.S. Food and Drug Administration (FDA). The recall affects over 1.8 million cartons of eye drops and is being coordinated in cooperation with healthcare distributor AvKARE.
Here’s what you need to know:
Why the recall was issued
- An FDA audit found violations of Current Good Manufacturing Practice (CGMP), which sets minimum standards for drug production.
- The FDA also cited a lack of assurance of sterility, meaning the products may not be free from harmful bacteria or other contaminants.
- While specific health risks were not detailed, CGMP violations can lead to unacceptable product quality, and patient risk cannot be ruled out.
Recalled eye care products
The following five products have been recalled:
- Artificial Tears Ophthalmic Solution
- Carboxymethylcellulose Sodium Ophthalmic Gel 1%
- Carboxymethylcellulose Sodium Ophthalmic Solution
- Lubricant Eye Drops Solution
- Polyvinyl Alcohol Ophthalmic Solution
Distribution details
- Products were shipped between May 26, 2023, and April 21, 2025.
- More than 1.8 million cartons are affected.
FDA recall classification
- The recall was categorized as Class II, defined as:
“A situation in which there is a reasonable probability that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
What consumers should do
- Stop using these eye drops immediately.
- Either dispose of them safely or return them to the place of purchase for a full refund.
- Consumers are urged to complete the recall notice (“Quantity to Return” and customer information sections) and send it via fax or email to AvKARE.
- Submit the form even if the product is no longer in your possession.
A full list of affected products is available through AvKARE’s official recall notice. If you experience any eye irritation or discomfort after using these products, consult a healthcare provider immediately.
Stay safe and informed — Healthy.mt will keep you updated on important product recalls that affect your health and wellness.
