Nearly 76,000 cases of potentially contaminated eye drops are being yanked from American shelves after the FDA discovered serious manufacturing violations that could put consumers’ eyesight at risk.
Key Takeaways
- The FDA announced a massive recall of over 75,000 cases of AvKare eye drops due to manufacturing violations that could compromise sterility
- Affected products were shipped between May 2023 and April 2025, with expiration dates ranging from April 2025 to March 2027
- The FDA classified the recall as Class II, indicating potential temporary or medically reversible adverse health consequences
- Consumers are advised to immediately stop using these products and can obtain a full refund, including shipping costs
- Eye drops bypass some of the body’s natural defenses, making sterility particularly crucial for these products
Another FDA Failure: Contaminated Products on Shelves for Years
The FDA has once again failed American consumers, allowing potentially dangerous eye care products to remain on shelves nationwide for nearly two years. BRS Analytical Services is recalling approximately 76,000 cases of eye drops manufactured for AvKare after an FDA audit revealed serious deviations from current Good Manufacturing Practices (cGMP). These manufacturing failures raise serious questions about product sterility – a critical issue for products applied directly to the eye.
“Ophthalmic drug products potentially pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” according to the FDA in its recall announcement.
Products Affected and Health Risks
The recalled products include various types of Artificial Tears Ophthalmic Solutions and Carboxymethylcellulose-based solutions, distributed widely across America. Most disturbing is the extended timeframe of potential exposure – these products were shipped from May 2023 through April 2025, with expiration dates ranging from April 2025 to March 2027. This means Americans may have been using compromised eye products for nearly two years while regulators failed to act promptly.
“The current health hazard posed to users of the eye drops is unknown, but possible risks cannot be ruled out,” said AvKare in their recall statement.
The FDA has classified this as a Class II recall, a designation that suggests the products “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” While the specific health hazards remain undefined, non-sterile eye drops can lead to infections, inflammation, and potentially serious complications. The recall notice warns that use of these products “should immediately cease.”
Manufacturing Violations and Regulatory Oversight
This recall stems directly from “manufacturing cGMP deviations identified during an audit by the FDA,” raising questions about the effectiveness of our regulatory oversight system. Good Manufacturing Practices are meant to ensure the “identity, strength, quality and purity of drug products.” The fact that these violations were only discovered during a routine audit – not proactive compliance monitoring, demonstrates the reactive rather than preventative approach of our regulatory bodies under the current administration.
“The drops, used to relieve itchy, dry eyes, were also recalled due to a ‘lack of assurance of sterility,'” stated the FDA in their recall announcement.
Consumer Advice and Response
Consumers are advised to immediately check their medicine cabinets for the affected products and discontinue use. AvKARE has notified suppliers to “examine your inventory to determine if you have any of the lots” affected and remove them from inventory. The company is offering full credit for returns, including shipping costs, through their recall process. Any adverse reactions should be reported to healthcare providers immediately, though the full scope of potential harm from these non-sterile products remains unknown.
“The preservative can cause the problems that the drop is supposed to help alleviate,” warned an unnamed medical expert quoted in reports about the recall.
This recall joins a troubling pattern of eye product recalls in recent years, highlighting systematic problems in manufacturing oversight and quality control in pharmaceutical production. President Trump’s administration has previously pushed for more stringent quality control standards for medical products, particularly those manufactured overseas, to protect American consumers from exactly these types of preventable safety concerns.
