What eye drops were recalled in 2025?

October 11, 2025 •

3 min read

Several batches of common eye drops and eye ointments were recalled throughout 2025 due to safety concerns identified by the U.S. Food and Drug Administration (FDA). These recalls highlight the ongoing importance for consumers to stay informed about product safety and know exactly what eye drops were recalled in 2025 to protect their vision.

Quick Summary

Several eye care products, including brands like Systane, AvKARE, and others from distributors like CVS Health and Equate, faced recalls throughout 2025. Issues ranged from fungal contamination to manufacturing deviations, prompting the FDA and manufacturers to issue alerts for consumer safety.

Key Points

Systane Recall: One lot of Systane Lubricant Eye Drops Ultra PF was recalled in early 2025 due to discovered fungal material in a single-use vial.
AvKARE Recall: In May 2025, numerous eye drops and gels distributed by AvKARE were recalled for manufacturing deviations and a lack of sterility assurance.
Eye Ointment Recall: Brassica Pharma initiated a recall for eye ointments sold under Equate, CVS Health, and AACE Pharmaceuticals brands due to sterility concerns in February 2025.
Check Your Products: Consumers should check NDC and lot numbers against official FDA and manufacturer recall lists to determine if their products are affected.
Stop Use Immediately: If you have a recalled product, you must stop using it immediately and dispose of it properly or return it to the point of purchase.
Report Adverse Events: Report any adverse reactions from eye drops to your healthcare provider and the FDA's MedWatch program.

Major eye drop and ointment recalls in 2025

Throughout 2025, several ophthalmic products were voluntarily recalled nationwide by manufacturers and distributors in cooperation with the FDA. These recalls addressed safety concerns such as potential fungal contamination and manufacturing issues, with affected products including popular brands and generic versions. Consumers and healthcare providers were urged to stop using these products immediately to avoid potential health risks.

Alcon recalls Systane eye drops

Alcon Laboratories issued a recall for one lot of Systane Lubricant Eye Drops Ultra PF, Lot 10101, in early 2025, following a consumer report of fungal material in a sealed vial. This posed a risk of eye infections, particularly for those with weakened immune systems.

AvKARE recalls ophthalmic solutions and gels

In May 2025, distributor AvKARE recalled various over-the-counter ophthalmic products after an FDA audit found manufacturing practice deviations that raised concerns about sterility. This FDA Class II recall affected products distributed from May 2023 to April 2025, including different types of artificial tears and gels.

Brassica Pharma recalls eye ointments

On February 26, 2025, eye ointments manufactured by Brassica Pharma Pvt. Ltd. were recalled due to sterility concerns. These products were sold under the Equate, CVS Health, and AACE Pharmaceuticals brands and were available at retailers like Walmart and CVS.

Apotex recalls prescription eye drops

In July 2025, Apotex recalled specific prescription eye drops, including a glaucoma treatment, due to an unspecified quality issue. Patients were advised to check if their medication batches were affected, specifically Ketorolac Tromethamine Ophthalmic Solution, 0.5% (Batch TZ1236), and Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5% (Batch VC6058).

Eye drop recalls in 2025: At a glance


Recall by	Distributor(s)	Products Recalled	Reason for Recall	Status
Alcon	Retail & Internet Outlets	Systane Lubricant Eye Drops Ultra PF, Lot 10101	Potential fungal contamination	Voluntary Nationwide Recall
BRS Analytical Service	AvKARE	Artificial Tears, Carboxymethylcellulose Gel & Solution, Lubricant Eye Drops, Polyvinyl Alcohol Ophthalmic Solution	Manufacturing deviations, lack of sterility assurance	FDA Class II Recall
Brassica Pharma	CVS, Walmart	CVS Health Lubricant Eye Ointment, Equate Lubricant Eye Ointment, AACE Pharma PM Ointment	Sterility concerns	FDA Recall Notice
Apotex	Various Healthcare Providers	Ketorolac Tromethamine Ophthalmic Solution, Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution	Unspecified quality issue leading to recall	Nationwide Recall

What to do if you have recalled eye drops

If you have a recalled eye product, immediately stop using it. You can return it to the place of purchase for a refund or dispose of it safely, following any specific instructions from the FDA or manufacturer. If you experience any adverse effects like pain or vision changes, contact a healthcare provider and inform them about the recalled product. You can also report adverse reactions to the FDA's MedWatch program.

Ensuring eye drop safety

To help ensure the safety of your eye drops, buy products from trusted retailers and check packaging for damage and expiration dates. Use products as directed by the manufacturer and store them properly to prevent contamination. Regularly checking the FDA's website for drug safety and recall information is also recommended. You can find this information on the FDA's drug safety and availability section online.

Conclusion

The 2025 eye drop and ointment recalls, involving products from brands like Systane, AvKARE, Equate, and CVS Health, underscore the critical need for strict manufacturing quality control. Issues such as fungal contamination and manufacturing practice violations can lead to serious health risks, including vision-threatening infections. Consumers should actively check for recalled products and immediately discontinue using any affected items. By staying informed and taking appropriate action, individuals can help protect their eye health. Healthcare providers and retailers are also key in removing recalled products and raising consumer awareness.

Frequently Asked Questions

If you used a recalled eye drop product, stop using it immediately. Monitor for any symptoms of eye infection, such as redness, pain, or blurry vision, and contact a healthcare provider if you have any concerns.

You can find lists of recalled eye drops on the U.S. Food and Drug Administration (FDA) website and by searching for recent news from major distributors and manufacturers like Alcon and AvKARE.

Recalls for sterility concerns occur when manufacturers fail to follow proper production guidelines, known as Current Good Manufacturing Practice (cGMP), leading to products that may be contaminated with bacteria or fungi.

Generally, yes, as recalls are typically limited to specific lot numbers or products. However, to be certain, always check the specific recall details and confirmation from official sources like the FDA.

The May 2025 recall involved multiple products, including various artificial tears, gels, and lubricant solutions distributed by AvKARE.

The recall for Systane Lubricant Eye Drops Ultra PF was due to potential fungal contamination, which could cause eye infections, particularly for individuals with weakened immune systems.

Follow the manufacturer's specific instructions for disposal, which often involves returning the product to the place of purchase. If that's not possible, dispose of it safely away from children and pets.