AvKARE has issued a voluntary recall affecting approximately 1.8 million cartons of eye drops and similar products following a recent audit by the Food and Drug Administration (FDA). The recall comes as a result of identified manufacturing and quality concerns.

Details of the Recall

The FDA has mandated the recall due to a “lack of assurance of sterility.” Although AvKARE has advised consumers to discontinue the use of the affected products, specifics about potential health risks have not been disclosed. The company emphasized that it cannot rule out the risks associated with using these products.

Affected Products

Consumers should be aware of the specific products subject to this recall:

• 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

These products were distributed between May 26, 2023, and April 21, 2025. For detailed information including lot numbers and expiration dates, visit the AvKARE recall page.

Consumer Safety Recommendations

AvKARE strongly advises all consumers to cease the use of the recalled eye products immediately. Customers can contact the company for a full credit, including return shipping costs.

The company expressed regret over any inconvenience this may cause, highlighting its commitment to consumer safety.

Background on Dry Eye Conditions

The recalled eye drops were designed to alleviate symptoms related to dry eye, a common condition impacting millions of Americans. Dry eye can occur when the eyes fail to produce sufficient tears or when the tears produced are of poor quality, leading to discomfort and potential vision issues.

Symptoms of dry eye may include scratchiness, stinging, redness, light sensitivity, and blurred vision. Effective management methods are available for those affected.

Current Context and Future Implications

This recall arises during a heightened demand for eye care products, particularly as allergy season intensifies, exacerbating symptoms for many individuals. Experts have noted that environmental changes contribute to an increase in allergy severity, affecting millions across the nation.