The healthcare product distribution company AvKARE has announced a voluntary recall for 5 eye drop products that may pose a health risk.
The FDA issue a Class II recall, warning about “cGMP deviations and lack of assurance of sterility,” which means that the eye drops may not be sterile due to manufacturing issues.
No infections were reported, but there may be an infection risk for people who use non-sterile eye drops that are contaminated with viruses, bacteria, fungi, or microbes.
The recall involves about 75,000 cases of eye drop products that were distributed nationwide by AvKARE, including:
- Artificial Tears Ophthalmic Solution (NDC# 50268-043-15)
- Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC# 50268-066-15)
- Carboxymethylcellulose Sodium Ophthalmic Solution (NDC# 50268-068-15)
- Lubricant Eye Drops Solution (NDC# 50268-126-15)
- Polyvinyl Alcohol Ophthalmic Solution (NDC# 50268-678-15)
AvKARE distributed these products over a two-year period, from May 26, 2023 through April 21, 2025.
AvKARE is urging customers to visit the recall website at https://www.avkare.com/recall, where you can see a list of specific lot codes and expiration dates on the recalled products.
This recall is just the latest a string of eye drop recalls in recent years, following a deadly outbreak of eye infections linked to EzriCare Artificial Tears in 2023. That outbreak infected at least 81 people in 18 states, including 4 people who died and 14 who went blind, according to the CDC.
Source: 75,000+ Cases of Eye Care Products Recalled Nationwide Over Sterility Concerns, FDA Says