What brands of eye drops are recalled?

October 9, 2025 •

3 min read

Since 2023, the FDA has coordinated several eye drop recalls impacting numerous brands due to serious contamination and manufacturing issues. This article provides a crucial breakdown of what brands of eye drops are recalled and why, to help protect your eye health.

Quick Summary

Major eye drop recalls have affected brands like EzriCare, Delsam Pharma, Systane, AvKARE, Refresh, and numerous store brands due to serious issues like bacterial and fungal contamination and manufacturing violations.

Key Points

EzriCare and Delsam Pharma (2023): These brands were recalled due to contamination with a rare, drug-resistant bacteria (Pseudomonas aeruginosa), leading to severe infections, vision loss, and death.
AvKARE (2025): Millions of AvKARE eye drops were recalled after an FDA audit found manufacturing and quality control issues, posing a risk of temporary or reversible health problems.
Systane (2024): One lot of Systane Ultra PF was recalled due to confirmed fungal contamination, which could cause vision-threatening infections.
Refresh (2024): Recalls were issued for certain lots of Refresh P.M. and Refresh Lacri-Lube eye ointments due to potential contamination caused by a tube sealing defect.
Store Brands (2023 & 2025): Multiple store-branded products from retailers like CVS, Rite Aid, Target, and Walmart have been recalled due to insanitary manufacturing conditions and potential sterility issues.
Actionable Advice: If you possess any recalled eye drop products, stop use immediately and dispose of them properly. Contact your healthcare provider if you have any signs of an eye infection.

In recent years, the eye care market has faced significant upheaval, with several large-scale recalls of popular eye drop and ointment products. These recalls, primarily initiated due to contamination risks or non-compliance with sterile manufacturing practices, have highlighted the importance of staying informed about product safety.

The EzriCare and Delsam Pharma Contamination (2023)

In early 2023, the U.S. saw a major recall of artificial tears manufactured by Global Pharma Healthcare. This was in response to a multistate outbreak of a rare, extensively drug-resistant strain of Pseudomonas aeruginosa, linked to severe infections, vision loss, bloodstream infections, and at least one death. FDA inspections revealed insanitary conditions and manufacturing practice violations, including inadequate microbial testing. The recalled products were EzriCare Artificial Tears, Delsam Pharma Artificial Tears, and Delsam Pharma Artificial Eye Ointment.

The AvKARE Recall (2025)

AvKARE initiated a voluntary recall in May 2025, involving millions of cartons of various eye drops and ophthalmic solutions. This was prompted by an FDA audit that identified manufacturing and quality issues at the facility of BRS Analytical Service, LLC. While no illnesses were reported, the potential for non-sterile or 'unacceptable quality' products led to a Class II recall. Recalled products included Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, and Lubricant Eye Drops Solution.

The Systane Fungal Contamination (2024)

In late 2024, Alcon Laboratories voluntarily recalled a specific lot of Systane eye drops after a customer complaint led to the discovery of fungal contamination. The FDA warned that fungal contamination could cause vision-threatening eye infections. The recalled product was Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101).

Refresh P.M. and Refresh Lacri-Lube Recall (2024)

Abbvie (Allergan) recalled multiple lots of Refresh P.M. and Refresh Lacri-Lube lubricant eye ointments in September 2024. The reason was a tube sealing issue that could cause leakage and potential contamination. This was a Class 2 recall, not announced directly to consumers but communicated to retail and healthcare professionals.

Comparison of Major Eye Drop Recalls (2023-2025)


Recall Period	Brands Involved	Reason for Recall	Severity / Associated Risks
Early 2023	EzriCare, Delsam Pharma	Bacterial contamination (Pseudomonas aeruginosa) due to insanitary manufacturing practices.	Serious: Vision loss, sepsis, and death reported.
Late 2023	CVS Health, Rite Aid, Target Up & Up, Leader, Rugby, Velocity	Insanitary manufacturing conditions at a facility used by multiple retailers.	Moderate to Serious: Risk of eye infections, vision loss.
Late 2024	Systane (Alcon)	Fungal contamination in a specific lot.	Moderate to Serious: Vision-threatening eye infections, especially for immunocompromised individuals.
September 2024	Refresh (Abbvie)	Tube seal issue leading to potential contamination.	Moderate: Risk of contamination and eye infections.
May 2025	AvKARE (BRS Analytical Service)	Unspecified manufacturing and quality control issues flagged by the FDA.	Low to Moderate: Potential for temporary or reversible health problems (Class II).
Feb 2025	Equate, CVS Health, AACE (Brassica Pharma)	Concerns about sterility assurance at the manufacturing facility.	Low: No adverse effects reported, but potential sterility compromise.

What to do if you have recalled eye drops

If you have products on this list, stop using them immediately. Dispose of the product safely and consult your doctor or pharmacist for a replacement. If you have experienced any adverse reactions, contact a healthcare provider immediately. Report any issues related to drug quality or side effects to the FDA's MedWatch program.

Conclusion

The series of eye drop recalls over the past few years serves as a critical reminder of the importance of pharmaceutical quality and safety. While many recalls are proactive measures, some, like the EzriCare incident, have been linked to devastating health outcomes. Consumers should always check for recall alerts and purchase from reputable sources. By remaining vigilant and informed, you can minimize your risk and protect your eye health.

For the most up-to-date information, always refer to official sources like the U.S. Food and Drug Administration's (FDA) recall website. The FDA provides current updates on recalls, market withdrawals, and safety alerts related to all drug products. You can find more information here: FDA Recalls, Market Withdrawals, & Safety Alerts.

Frequently Asked Questions

Check your product's brand name, lot number, and expiration date against the official recall lists provided by the FDA, found on their website. For recent and specific recalls, check retailer-specific notices or news alerts, as some recalls are not broadly publicized.

Stop using the product immediately. Dispose of it safely and return it to the point of purchase for a refund, if possible. Do not put contaminated drops back in your eyes.

Symptoms can include eye pain, redness, blurry vision, increased sensitivity to light, or yellow, green, or clear discharge from the eye.

Contact your healthcare provider or seek medical care immediately if you experience any signs or symptoms of an eye infection. You should also report the issue to the FDA's MedWatch Adverse Event Reporting program.

Not necessarily. Recalls often affect only specific products or lot numbers manufactured during a certain period. However, given the potential risks, it is safest to assume the worst and stop using any product from a brand with a recent contamination recall, unless you can confirm it is not an affected lot.

Recent recalls are largely due to stricter FDA scrutiny and manufacturing practice issues found during inspections, particularly in facilities outside the U.S. These issues have led to potential or confirmed contamination with bacteria, fungi, or other quality problems.

Yes, it is generally safe to buy store-brand eye drops that have not been recalled. However, it is prudent to check for recent recall alerts before purchasing and to stay informed about product safety warnings. Buying from reputable retailers and checking the FDA website for updates is a good practice.