The FDA has announced a nationwide recall of nearly 76,000 cases of eye drops and artificial tears due to significant manufacturing violations that raised concerns about product quality and sterility.
Reason for the Recall
The recall was initiated after an FDA inspection at BRS Analytical Service, a pharmaceutical testing laboratory and manufacturer, uncovered multiple deviations from Current Good Manufacturing Practice (cGMP) standards. These violations included a lack of assurance of sterility, meaning the products might not be free from harmful microorganisms, which is critical for any product applied to the eyes. The FDA classified the recall as Class II, indicating that use of these products could result in temporary or medically reversible adverse health consequences, although the risk of serious injury is considered remote.
Products Affected
The recall involves several prescription-grade ophthalmic solutions distributed by AvKare between May 26, 2023, and April 21, 2025. The affected products include:
- Artificial Tears Ophthalmic Solution (Dextran 70.01%, Glycerin 0.2%, Hypromellose 0.3%)
- Carboxymethylcellulose Sodium Ophthalmic Gel 1%
- Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
- Lubricant Eye Drops Solution (Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%)
- Polyvinyl Alcohol Ophthalmic Solution 1.4%
These products were distributed nationwide, but the specific brand names and retail outlets have not been disclosed.
Health Risks and Consumer Guidance
While no illnesses or injuries have been reported to date, the recall was issued out of an abundance of caution. The lack of sterility could potentially expose users to eye infections or other complications. Consumers are urged to stop using these products immediately and consult their healthcare provider if they experience any symptoms such as eye redness, pain, discharge, or vision changes.
Healthcare providers are also advised to remove any affected inventory from their shelves and follow AvKare’s recall instructions for returns and refunds.
Background
This recall follows a series of FDA actions over the past two years targeting eye care products with manufacturing and contamination issues. Previous recalls have been associated with serious infections and, in rare cases, vision loss or hospitalization.
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