Which Brands of Eye Drops are Being Recalled?

Recent years have seen an unusually high number of eye drop recalls due to serious issues like bacterial and fungal contamination. It is crucial to know which brands of eye drops are being recalled and the potential risks involved.

Quick Summary

Several brands of eye drops have faced recalls recently due to sterility issues and potential contamination. Consumers should check for affected products from brands like AvKARE, Alcon (Systane), and store brands from retailers including CVS, Rite Aid, and Walmart.

Key Points

• Recent recalls include AvKARE and Alcon (Systane): In May 2025, AvKARE recalled multiple products due to manufacturing issues, while Alcon recalled a specific lot of Systane eye drops in late 2024 due to fungal contamination.

• Significant 2023 recalls affected numerous store brands: Products manufactured by Kilitch Healthcare, including store brands from CVS Health, Rite Aid, Target, and Walmart, were recalled due to unsanitary factory conditions.

• Contaminated eye drops pose serious health risks: Past recalls, like the EzriCare and Delsam Pharma products in early 2023, were linked to severe bacterial infections, vision loss, and even death.

• Verify products using the FDA database: Consumers should check the FDA's recall database, cross-referencing brand names, lot numbers, and expiration dates from their packaging to verify if a product is affected.

• Stop using recalled products immediately: If a recalled product is owned, stop using it at once, secure it, and consult a healthcare provider if any symptoms of an eye infection are experienced.

• Be cautious of online purchases: The FDA has warned against unapproved and potentially harmful 'copycat' drops sold online, such as South Moon and Rebright.

Navigating the constant stream of product safety alerts can be challenging for consumers. Recent and ongoing recalls of eye drops have drawn particular attention, with the U.S. Food and Drug Administration (FDA) issuing numerous warnings regarding potential risks ranging from contamination to improper manufacturing. This comprehensive guide provides details on the most significant and recent recalls affecting various brands and products.

Recent Eye Drop Recalls in 2024 and 2025

The most recent eye drop recalls involve both store brands and widely known names, prompting immediate action from manufacturers and retailers. Staying up-to-date on these alerts is essential for protecting eye health.

AvKARE/BRS Analytical Service, LLC Recall (May 2025)

In May 2025, AvKARE initiated a voluntary nationwide recall of specific eye care products manufactured by BRS Analytical Service, LLC. This recall was due to Current Good Manufacturing Practice (cGMP) deviations found during an FDA audit. The affected items, including both ophthalmic gels and solutions, were shipped between May 26, 2023, and April 21, 2025. The recall is designated as Class II, although no adverse events had been reported at the time of the announcement. The specific products are identified by their National Drug Code (NDC) numbers:

• NDC# 50268-043-15 Artificial Tears Ophthalmic Solution
• NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
• NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution
• NDC# 50268-126-15 Lubricant Eye Drops Solution
• NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution

Alcon (Systane) 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 prompted by a customer complaint about a foreign material in a sealed vial, which the company identified as potential fungal contamination. While no adverse events were reported, the specific product lot (Lot 10101) with an expiration date of 2025/09 was affected and distributed nationwide. This recall is significant because it involves a popular, well-known brand, demonstrating that recall issues are not limited to lesser-known manufacturers.

FDA Warning on Copycat Eye Drops (January 2024)

In January 2024, the FDA warned consumers not to purchase or use South Moon, Rebright, or FivFivGo eye drops, citing the risk of eye infection. These products were marketed as resembling Bausch + Lomb's Lumify brand and were not FDA-approved, highlighting a separate category of safety risk related to illegally marketed products.

Significant Recalls from 2023

Several major eye drop recalls occurred throughout 2023, largely due to unsanitary manufacturing conditions and bacterial contamination. These incidents serve as a stark reminder of the importance of pharmaceutical quality control.

Kilitch Healthcare and Associated Store Brands (October/November 2023)

A widespread recall in late 2023 affected dozens of products manufactured by Kilitch Healthcare India Limited. The FDA found insanitary conditions at the manufacturing facility and confirmed bacterial contamination in production areas. The recall impacted numerous store-branded products, including those sold at:

• CVS Health: Various lubricant eye drops and gel drops
• Rite Aid: Various lubricant eye drops and multi-action relief drops
• Target (Up&Up): High performance and dry eye relief lubricant eye drops
• Walmart (Equate): Lubricant eye ointment and hydration drops
• Leader (Cardinal Health): Various lubricant eye drops and eye irritation relief drops
• Rugby (Cardinal Health): Various lubricating eye drops

EzriCare and Delsam Pharma Recall (February 2023)

One of the most severe eye drop recalls in recent history involved products from Global Pharma Healthcare, which were distributed under the EzriCare and Delsam Pharma brand names. These artificial tears and ointments were linked to a multistate outbreak of a rare, extensively drug-resistant strain of Pseudomonas aeruginosa bacteria. The outbreak led to numerous infections, vision loss, and deaths, and prompted the CDC and FDA to issue urgent warnings.

Dr. Berne's and LightEyez MSM Drops (August 2023)

In August 2023, the FDA issued warnings against using Dr. Berne's MSM Drops 5% Solution and LightEyez MSM Eye Drops-Eye Repair. The drops were found to be non-sterile and contained methylsulfonylmethane (MSM), an unapproved and potentially harmful active ingredient for ophthalmic use.

How to Identify and Verify Recalled Eye Drops

Verifying if a product you own is affected by a recall is a critical step for safety. Simply checking a brand name is not enough; you must also confirm lot numbers and expiration dates.

Steps to Verify Your Product:

1. Stop Use Immediately: If you suspect eye drops are part of a recall, stop using them immediately, even if they appear normal. Contaminated products may not show visible signs of spoilage.
2. Check the FDA Recall Database: Visit the FDA's website and search their Recalls, Market Withdrawals, & Safety Alerts page. Enter the brand name and look for the specific product, NDC number, lot number, and expiration date.
3. Examine Your Packaging: Cross-reference the NDC, lot, and expiration information on the eye drop container with the details listed in the official recall notice.
4. Contact the Manufacturer/Retailer: If in doubt, contact the manufacturer or the retailer where you bought the product for clarification. Major retailers like CVS and Walmart have procedures for returning recalled products.

Important Comparison Table: Key Eye Drop Recalls

Recall Date	Brands/Products	Manufacturer/Distributor	Reason for Recall
May 2025	AvKARE Artificial Tears & Ophthalmic Solutions	BRS Analytical Service, LLC (manufacturer); AvKARE (distributor)	Current Good Manufacturing Practice (cGMP) deviations
Dec 2024	Systane Lubricant Eye Drops Ultra PF (Lot 10101)	Alcon Laboratories	Potential fungal contamination
Oct/Nov 2023	CVS Health, Rite Aid, Target Up&Up, Walmart Equate (store brands), Leader, Rugby	Kilitch Healthcare India Limited	Insanitary manufacturing conditions and bacterial test results
Feb 2023	EzriCare Artificial Tears, Delsam Pharma Artificial Tears & Ointment	Global Pharma Healthcare (manufacturer); EzriCare, LLC and Delsam Pharma (distributors)	Contamination with drug-resistant Pseudomonas aeruginosa bacteria
Aug 2023	Dr. Berne's MSM Drops, LightEyez MSM Eye Drops	Dr. Berne's & LightEyez	Non-sterility and use of unapproved ingredient (MSM)

What to Do If You Have Recalled Eye Drops

If a recalled eye drop product is in possession, follow these steps to ensure safety:

• Stop Use Immediately: Do not use the product, regardless of whether any adverse effects have been experienced. The risk of serious eye infections is real, even without visible contamination.
• Secure the Product: Store the product in a safe place away from children and pets. Do not immediately discard it, as it may serve as evidence if a reaction is experienced later.
• Return for Refund: Return the product to the place of purchase or contact the manufacturer for a refund. Most retailers and manufacturers accept returns of recalled items, often without a receipt.
• Monitor for Symptoms: Pay close attention to eyes for any signs of infection, such as discharge, pain, redness, swelling, or blurred vision.
• Contact Your Healthcare Provider: If a recalled eye drop was used and any eye infection symptoms are experienced, contact a healthcare professional or eye doctor immediately for evaluation and treatment.
• Report Adverse Events: Consider reporting any adverse reactions or product issues to the FDA's MedWatch Adverse Event Reporting program.

Conclusion

The recent surge in eye drop recalls underscores the critical need for vigilance among consumers. While regulatory bodies like the FDA work to remove unsafe products, the final responsibility lies with individuals to check products and respond swiftly to safety alerts. Staying informed about which brands of eye drops are being recalled, understanding the risks, and knowing what steps to take can prevent serious health complications. Always consult with a healthcare provider for specific recommendations, especially if chronic eye conditions are present or if eye drops are being used frequently. For the most current information, regularly check the official FDA website for recalls and safety alerts.

• Outbound Link: FDA Recalls, Market Withdrawals, & Safety Alerts

Frequently Asked Questions

How can one tell if eye drops have been recalled?

To check if eye drops have been recalled, visit the official FDA recall database and search for the product's brand name, NDC number, and lot number, which are printed on the packaging. Contact the store where the drops were purchased.

What should be done if recalled eye drops are at home?

Stop using the recalled eye drops immediately. Return the product to the place of purchase for a refund and store it securely away from others. Do not use the product even if no problems have been experienced.

What are the common reasons for eye drop recalls?

Eye drop recalls can occur for several reasons, including bacterial or fungal contamination due to unsanitary manufacturing conditions, lack of sterility assurance, use of unapproved ingredients, or faulty packaging that compromises product sterility.

What are the symptoms of an eye infection from contaminated eye drops?

Symptoms of an eye infection can include redness, swelling, pain or discomfort, discharge from the eye, sensitivity to light, and blurred vision. Seek immediate medical attention if any of these symptoms are experienced after using eye drops.

Are all eye drops from a recalled brand unsafe?

No, often a recall affects only specific lots, batches, or product types from a brand, not the entire product line. It is crucial to check the specific lot number and expiration date on the eye drops against the information in the official recall notice.

Are only generic or store-brand eye drops recalled?

No, while some recalls have involved store brands like CVS Health and Walmart Equate, well-known brands such as Alcon's Systane have also had recalls. It is important to check the FDA recall list regardless of the brand name.

Where can one find the most up-to-date information on eye drop recalls?

The most reliable and current source for information on eye drop recalls is the official FDA website, which publishes recalls, market withdrawals, and safety alerts. Sign up for email updates from the FDA.