AvKARE Eye Drops were recalled due to manufacturing problems and a possible lack of sterility, which may pose a risk of eye infections.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting AvKARE Eye Drops infection cases in all 50 states. If you were diagnosed with a severe eye infection after using contaminated eye drops, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
AvKARE Eye Drops Recalled for Safety Risks
In May 2025, AvKARE and the FDA announced a recall for over 75,000 cases of eye drops and artificial tears due to safety concerns, including “cGMP deviations and a lack of assurance of sterility,” which could pose a risk of eye infections.
What Eye Drops Were Recalled?
The recall involves 5 eye drop products that were distributed nationwide by AvKARE:
- 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)
How To Identify Recalled Eye Drops
These recalled eye drop products were shipped nationwide over a two-year period, between May 26, 2023 and April 21, 2025.
For specific lot codes and expiration dates, see the AvKARE recall website at: https://www.avkare.com/recall.
Why Were AvKARE Eye Drops Recalled?
The eye drops were also recalled due to “manufacturing cGMP deviations identified during an audit by the FDA,” which is a reference to the current rules for Good Manufacturing Practices (cGMP).
The voluntary recall was announced by healthcare distributor AvKARE, which urged suppliers to “examine your inventory to determine if you have any of the lots” that have been recalled.
What is the Risk?
AvKARE did not say what safety risks are linked to the manufacturing issues, but the company warned that customers should immediately stop using the eye drops due to “unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.”
Symptoms of an Eye Infection
Eye infections occur when bacteria, fungi, viruses, or parasites get in the eye and grow. The symptoms of an eye infection include:
- Eye discomfort or pain
- Redness
- Itchy eyes
- Swelling of the eyelids
- Discharge from the eyes
- Sensitivity to light
- Blurry vision
- Vision loss
- Symptoms in other parts of the body (headache, fever, fatigue, swollen lymph nodes, etc.)
Eye Drop Recalls
The AvKARE eye drop recall in May 2025 follows other eye drop recalls. For example, in December 2024, Systane Eye Drops were recalled due to a potential risk of fungal contamination.
Eye Drops Linked to Deadly Infection Outbreak
In 2023, a contaminated eye drop product called EzriCare Artificial Tears was recalled after 81 people in 18 states developed infections. Four people who died when infections spread to their blood. At least 14 people lost their vision.
CVS, Walmart, Target, Other Retailers Recall Eye Drops
Later in 2023, the FDA also issued Safety Warning for dozens of eye drop products “due to the potential risk of eye infections that could result in partial vision loss or blindness,” including products from CVS, Target Up & Up, Walmart Equate, Rite Aid, Leader (Cardinal Health), Rugby (Cardinal Health), Velocity Pharma, Kilitch Healthcare, and more.
Do I Have an AvKARE Eye Drops Lawsuit?
The Schmidt Firm, PLLC is currently accepting AvKARE Eye Drops infection cases in all 50 states. If you were diagnosed with a severe eye infection after using contaminated eye drops, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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