Yet another eye drop recall exposes the FDA’s inability to protect Americans from basic health hazards, as 75,000 cases of potentially dangerous products make it to store shelves.
Quick Takes
- AvKARE’s over-the-counter eye drops face urgent recall due to safety concerns affecting products shipped between May 2023 and April 2025
- The FDA identified “deviations from Current Good Manufacturing Practice regulations” at the manufacturing facility
- Over 75,000 cases of eye care products are affected by this recall due to “lack of assurance of sterility”
- This follows another recent eye drop recall from Alcon Laboratories due to fungal contamination concerns
- Consumers are urged to immediately stop using these products and can receive full credit for returns
Another FDA Failure: Massive Eye Drop Recall Threatens Consumer Safety
The FDA has announced yet another urgent recall of over-the-counter eye drops, this time targeting products distributed by AvKARE after manufacturing defects were identified. This massive recall affects 75,000 cases of eye care products shipped over nearly a two-year period between May 26, 2023, and April 21, 2025. The affected products include Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Lubricant Eye Drops Solution, and various other eye lubricants designed to relieve dry and irritated eyes.
Once again, the FDA appears to be reacting to problems rather than preventing them. The recall was triggered after an FDA audit at BRS Analytical Service uncovered “deviations from Current Good Manufacturing Practice regulations.” These defects were serious enough to warrant immediate action, with the manufacturer admitting they “may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.” This raises troubling questions about the effectiveness of the FDA’s inspection and approval processes.
Potential Health Hazards and Government Response
The FDA has classified this as a “health hazard,” though in typical bureaucratic fashion, they’ve been vague about the specific risks to consumers. What we do know is that the recall centers around a “lack of assurance of sterility” – a critical safety issue for products applied directly to the eyes. Eye infections can lead to serious complications including vision loss, particularly in vulnerable populations. This widespread safety concern follows a disturbing pattern of eye drop recalls in recent years, raising questions about whether manufacturers are cutting corners and if regulatory oversight is adequate.
The timing of this recall is particularly troubling. How were potentially dangerous eye drops distributed and sold for nearly two years before anyone noticed a problem? The FDA’s recall classification system categorizes recalls into three levels based on risk: Class I (high risk), Class II (moderate risk), and Class III (low risk). Despite the potential for serious eye infections or injuries, the agency’s response appears delayed and reactive rather than proactive, once again putting Americans’ health at risk.
Industry Pattern: Alcon’s Recent Recall
This isn’t an isolated incident in the eye care industry. Alcon Laboratories recently issued their own recall on December 23, 2024, for a specific Systane product due to fungal contamination concerns. The pattern suggests a troubling trend of quality control issues across the eye care product industry that regulators are failing to address systematically. When companies face minimal consequences for shipping potentially dangerous products, and regulators move at a glacial pace, American consumers are left vulnerable.
Consumers stuck with these potentially dangerous products must now navigate a bureaucratic return process. AvKARE has promised “full credit including shipping cost for any returns,” but this requires filling out recall forms, faxing or emailing documentation, and shipping products to R&S Northeast LLC in Fountain Run, KY. While the company characterizes this as an “inconvenience,” the reality is that consumers have been exposed to potential health risks and now face the burden of dealing with the aftermath of regulatory failure.
Protecting Yourself When Regulators Fail
With the federal government apparently unable or unwilling to protect Americans from basic health hazards, consumers must take their own precautions. Healthcare experts recommend alternatives for those dealing with dry, itchy, or irritated eyes, including using warm compresses, increasing bedroom humidity, and using specific cleansing products. Those experiencing eye discomfort should consult with an eye care professional rather than relying on potentially unsafe over-the-counter solutions that may have slipped through inadequate regulatory oversight.
Americans deserve better than regulators who react to problems rather than prevent them. This massive recall underscores the need for stronger oversight of manufacturing facilities, especially for products that could cause serious harm if contaminated. Until meaningful reforms are implemented, consumers must remain vigilant about the products they use and hold both manufacturers and regulatory agencies accountable for protecting public health rather than merely responding to crises after the damage has been done.
