The High-Profile 2023 Contamination Recalls
In what was one of the most serious eye care product recalls in recent history, the CDC and FDA issued a major warning in February 2023 against the use of EzriCare Artificial Tears and Delsam Pharma Artificial Tears. Both products were manufactured by the same company, Global Pharma Healthcare.
The recall was triggered after the products were linked to an outbreak of a rare, antibiotic-resistant strain of Pseudomonas aeruginosa bacteria. This led to a multi-state investigation that uncovered dozens of cases of eye infections, many resulting in vision loss, and tragically, at least one death from a bloodstream infection. The severe consequences highlighted the dangers of using contaminated ophthalmic products, particularly those without preservatives intended for single use but sold in multi-use bottles, as was the case here.
Why These Two Products? A Closer Look at the Global Pharma Recall
The FDA's inspection of the manufacturing facility in India revealed multiple serious violations of Current Good Manufacturing Practice (cGMP). These unsanitary conditions allowed for contamination of the product during production. For consumers, this recall was particularly alarming due to the aggressive, drug-resistant nature of the bacteria involved, which proved difficult to treat with standard antibiotics. The FDA and CDC urged consumers to immediately stop using and discard these products and to seek medical attention if they had used them and experienced any symptoms of infection.
More Recent Eye Drop Recalls in 2024 and 2025
While the 2023 EzriCare and Delsam Pharma recall remains a key point of reference, the FDA has continued to issue recalls for other eye drops and ophthalmic products due to different safety concerns. This demonstrates that manufacturing issues are a persistent risk across the industry.
Systane Lubricant Eye Drops Recall (December 2024)
In December 2024, Alcon Laboratories voluntarily recalled a single lot of its Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go. The recall was initiated after a consumer complaint regarding foreign material inside a sealed vial, which was identified as a fungus. Fungal contamination poses a risk of eye infection, which could be vision-threatening, especially for immunocompromised individuals. Though no adverse events were reported for this specific lot, the recall served as a precautionary measure to protect consumer health.
AvKARE-Distributed Ophthalmic Products Recall (May 2025)
In May 2025, distributor AvKARE issued a voluntary recall for several ophthalmic products, including eye drops, artificial tears, and gels, manufactured by BRS Analytical Services. This recall was not based on reported adverse events but rather on FDA findings of manufacturing cGMP deviations and a "lack of assurance of sterility". The recall was classified as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences. Affected products included Artificial Tears Ophthalmic Solution and Lubricant Eye Drops Solution.
Comparing Notable Eye Drop Recalls
| Feature | EzriCare & Delsam Pharma (2023) | Systane Lubricant Eye Drops (2024) | AvKARE/BRS Analytical (2025) |
|---|---|---|---|
| Manufacturer/Distributor | Global Pharma Healthcare (manufacturer); EzriCare and Delsam Pharma (distributors) | Alcon Laboratories (manufacturer) | BRS Analytical Services (manufacturer); AvKARE (distributor) |
| Reason for Recall | Contamination with drug-resistant Pseudomonas aeruginosa bacteria. | Fungal contamination observed in a sealed vial. | Manufacturing deviations and lack of sterility assurance. |
| Health Risk | Serious eye infections, vision loss, and bloodstream infections. | Potential for eye infections, especially for immunocompromised individuals. | Remote possibility of adverse health consequences. |
| Recall Scope | All unexpired EzriCare and Delsam Pharma Artificial Tears. | One specific lot number (10101) of Systane Ultra PF single vials. | Several ophthalmic solutions shipped between May 2023 and April 2025. |
What to Do If You Have Recalled Eye Drops
First and foremost, if you are in possession of any recalled eye drops, you should immediately stop using them and discard them. It is not safe to use or return them to the place of purchase. If you have any concerns about an eye drop product you are using, always err on the side of caution.
Here are the recommended steps:
- Check the recall notice: Verify the product name, lot number, and expiration date against the official FDA recall notice. The lot number and expiration date are typically printed on the bottle and the outer packaging.
- Contact your healthcare provider: If you have used a recalled product and are experiencing any signs of eye infection, such as redness, discharge, pain, or blurred vision, contact an eye care professional immediately.
- Report adverse events: You can report any adverse reactions or product quality issues to the FDA's MedWatch Adverse Event Reporting program. This helps the FDA track potential issues and take action when necessary. You can submit reports online or by phone.
The Larger Context of Eye Drop Safety
These recalls, particularly the EzriCare and Delsam Pharma incident, have brought increased scrutiny to the manufacturing practices of over-the-counter ophthalmic products. Eye drops are required to be sterile, and any manufacturing breach can have serious consequences for consumers. While the vast majority of eye drops are safe, these incidents serve as an important reminder for both consumers and manufacturers to maintain vigilance. Consumers should purchase products from reputable sources and be aware of recall notices, while manufacturers must uphold the highest standards of sterility and quality control to prevent future harm.
Conclusion
For those asking which two eye drops were recalled in the most significant recent event, the answer is EzriCare Artificial Tears and Delsam Pharma Artificial Tears, which were linked to a dangerous bacterial outbreak in early 2023. However, it is crucial to recognize that numerous other eye drop and ointment recalls have occurred since, highlighting persistent manufacturing and contamination issues across the industry. Staying informed through official FDA channels and being proactive about checking your products remains the best defense against potential harm. The safety and sterility of ophthalmic products are paramount for protecting vision and overall health. For the most up-to-date information on any drug or product recall, refer to the official FDA website.
- Official FDA Recall Information: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
