Eye Care Alert: What You Need to Know About Recent Product Recall

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FDA finds “insanitary conditions” at eye drop manufacturing facilities, prompting an urgent nationwide recall of 26 products sold at major retailers that could cause blindness.

Key Takeaways

  • Multiple over-the-counter eye care products from major retailers including Walmart, CVS, Rite Aid, and Target are being recalled due to FDA-identified manufacturing violations that could lead to vision loss or blindness.
  • Products were distributed between May 2023 and April 2025, with bacterial contamination discovered during FDA inspection of manufacturing facilities.
  • Affected brands include CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up & Up, and Velocity Pharma, among others.
  • Consumers should immediately stop using all recalled products and check the FDA’s detailed list of affected items by their National Drug Codes (NDCs).

Another Regulatory Failure Puts Americans at Risk

The FDA has issued a warning against using 26 over-the-counter eye drop products sold by major retailers across America after discovering “insanitary conditions” and positive bacterial test results at manufacturing facilities. The products, distributed between May 26, 2023, and April 21, 2025, include various ophthalmic solutions and gels such as Artificial Tears and Carboxymethylcellulose Sodium Ophthalmic Gel. This widespread contamination risk remained undetected for nearly a year before officials took action.

Kilitch Healthcare India Limited has voluntarily recalled these products following the FDA audit that revealed serious manufacturing violations. Cardinal Health Inc. has also recalled all lots of six Leader brand ophthalmic products, while Harvard Drug Group LLC pulled all lots of two Rugby Laboratories brand eye drops. This extensive recall raises questions about the FDA’s oversight of foreign manufacturing facilities and the agency’s ability to protect American consumers from potentially dangerous imported healthcare products.

Major Retailers Scramble to Remove Dangerous Products

CVS, Rite Aid, Target, and Walmart are removing these potentially contaminated eye care products from their shelves and websites—though the FDA warns some products may still be available for purchase. Walmart-specific products like Equate Hydration PF Lubricant Eye Drop are included in the recall. The fact that these contaminated products made it to market in the first place highlights troubling gaps in quality control and inspection processes that should have caught these issues before they reached American consumers.

While no adverse events have been officially reported to the FDA yet, the agency is encouraging consumers who experience problems to report them through the MedWatch Adverse Event Reporting program. The contamination risks are severe—potentially causing eye infections that could lead to partial vision loss or complete blindness. This recall demonstrates yet another alarming failure of our regulatory agencies to properly inspect and verify the safety of imported healthcare products before they reach American consumers.

Consumer Action and Government Accountability

BRS Analytical Service announced the recall of multiple products due to violations of good manufacturing practices, although the company has carefully avoided specifying exactly what health hazards are present. The lack of transparency is concerning, especially considering these products are applied directly to one of the most sensitive and important organs in the human body. Americans deserve better oversight and accountability from both manufacturers and the government agencies tasked with protecting public health.

Consumers are advised to immediately check their medicine cabinets and dispose of any recalled eye care products. The FDA has published a comprehensive list of affected products with their National Drug Codes (NDCs) for reference. This incident serves as yet another reminder that American consumers must remain vigilant about the products they use, as regulatory oversight continues to fall short of protecting citizens from dangerous foreign-manufactured healthcare products. The FDA must be held accountable for allowing these contaminated products into the U.S. market in the first place.

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