Understanding the Eye Drop Contamination Issue
Eye drops are sterile products by design, as they are applied directly to the sensitive surface of the eye. When a non-sterile or contaminated product is introduced, it bypasses the body's natural defense mechanisms, allowing harmful pathogens to cause severe eye infections. The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) monitor product safety and issue recalls when risks are identified, protecting consumers from potentially sight-threatening complications.
Recent Eye Drop Recalls Due to Contamination
Multiple eye drop products have faced recalls in recent years due to contamination concerns. These incidents highlight the importance of stringent manufacturing practices and consumer vigilance.
The 2023 EzriCare Bacterial Outbreak
In early 2023, EzriCare Artificial Tears and other products from Global Pharma Healthcare were recalled. This was linked to a multi-state outbreak of a rare, drug-resistant Pseudomonas aeruginosa. The outbreak caused at least 68 infections, resulting in vision loss, surgical eye removal, bloodstream infections, and death. An FDA investigation found the manufacturer failed to meet manufacturing standards, with inadequate testing and packaging issues. This led the FDA to place the manufacturer on import alert.
The 2024 Fungal Contamination: Systane Recall
Alcon Laboratories issued a voluntary recall in late 2024 for a specific lot of Systane Lubricant Eye Drops Ultra PF (Lot 10101) due to fungal contamination. The contamination was discovered after a customer complaint of foreign material in a single-use vial. Fungal contamination poses a risk of vision-threatening eye infections, particularly for immunocompromised individuals. The FDA advised consumers to stop using the product immediately.
The 2025 Sterility Concerns: AvKare and BRS Analytical Service
In May 2025, several ophthalmic solutions distributed by AvKare and manufactured by BRS Analytical Service were recalled due to concerns about manufacturing quality and sterility. An FDA audit revealed deviations from good manufacturing practices, resulting in a “lack of assurance of sterility” for products distributed between May 2023 and April 2025. The recall included specific artificial tears, lubricant gels, and ophthalmic solutions. While specific health risks weren't fully determined, the sterility issue meant patient risk couldn't be ruled out.
Other Notable Recalls
Additional recalls in recent years include:
- February 2024: Brassica Pharma Pvt. Ltd. recalled specific lots of Equate and CVS Health lubricant eye ointments due to potential sterility issues.
- November 2023: The FDA alerted consumers to stop using numerous over-the-counter eye drops from manufacturers like Kilitch Healthcare India due to potential sterility issues.
- September 2024: Allergan recalled some Refresh P.M. and Refresh Lacri-lube ointments due to breaches in tube seals, creating a contamination risk.
Comparison of Major Eye Drop Recalls
| Recall Event | Affected Products | Contaminant/Issue | Date | Health Risk |
|---|---|---|---|---|
| EzriCare/Delsam | Artificial Tears, Artificial Eye Ointment | Pseudomonas aeruginosa (drug-resistant) | Feb 2023 | Severe eye infection, vision loss, death |
| AvKare/BRS Analytical | Artificial Tears, gels, ophthalmic solutions | Lack of sterility (cGMP deviation) | May 2025 | Unacceptable quality, infection risk |
| Alcon Systane Ultra PF | Lubricant Eye Drops (Lot 10101) | Fungal material | Dec 2024 | Vision-threatening eye infection |
| Allergan Refresh | Refresh P.M., Refresh Lacri-lube ointments | Breaches in tube seals | Sep 2024 | Contamination risk |
What to Do If You Have a Recalled Product
If you have a recalled eye drop product, immediately stop using it. Check the recall notice to confirm if your product is affected by matching lot numbers, UPC codes, and expiration dates. Follow instructions for disposal or return for a refund or replacement. Monitor for symptoms of eye infection and seek medical attention if they appear. Report any adverse events to the FDA's MedWatch program.
Identifying Symptoms of a Contaminated Eye Drop Infection
Symptoms of an eye infection from contaminated drops include eye irritation or pain, redness, discharge, sensitivity to light, blurred vision, and a feeling of a foreign object in the eye. An allergic reaction is also possible. If you experience any of these, consult a healthcare provider immediately.
Protecting Yourself from Contaminated Eye Drops
To protect yourself, regularly check the FDA website for recalls. Inspect packaging for damage before use. Use eye drops as directed and discard them properly after opening. Purchase products from reputable sources and be aware of recent recall patterns often linked to manufacturing issues.
Conclusion
The series of recent eye drop recalls, from bacterial and fungal contaminations to sterility issues, highlights the critical importance of ensuring product safety. By staying informed about which eye drops have been recalled due to contamination, consumers can protect their eye health. Always consult the FDA website for the latest recall information and practice good eye hygiene. While recalls are a concern, they affect specific products, and most eye drops remain safe when used as directed.
- For the most current list of recalled products, visit the U.S. Food and Drug Administration's Recalls, Market Withdrawals, & Safety Alerts page.
