AvKare recalls over-the-counter eye drops after FDA audit

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A action of oculus drops statement a support astatine a drugstore successful Los Angeles successful December 2023.

A action of oculus drops statement a support astatine a drugstore successful Los Angeles successful December 2023. Richard Vogel/AP hide caption

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Richard Vogel/AP

Pharmaceutical institution AvKare has issued a voluntary callback connected respective of its over-the-counter products for barren and irritated eyes, citing regulatory "deviations" identified during an audit by nan Food and Drug Administration.

"Health Hazard to nan personification is unknown," AvKare said successful a statement connected its website. The "deviations whitethorn lead to products of unacceptable quality, and it is not imaginable to norm retired diligent risks resulting from usage of these products."

These deviations could beryllium thing from issues pinch packaging to problems that occurred during manufacturing. AvKare did not specify what issues had been identified.

The Food and Drug Administration office successful Silver Spring, Md.

The 5 recalled products see lubricant oculus drops and oculus gels, which consumers should instantly cease using, AvKare warned. The items affected were shipped May 26, 2023 done April 21, 2025.

The products are:

  • 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

Neither AvKare nor nan FDA responded to NPR's requests for comment.

AvKare said customers are eligible for a afloat refund connected their affected products, including nan costs of shipping nan returns.

Over-the-counter eye treatments person made headlines successful recent years aft a spate of contamination issues affected dozens of brands. Some of nan affected products successful past recalls included oculus drops from national brands for illustration CVS Health, Target and Rite Aid.