Since 2023, the U.S. Food and Drug Administration has issued multiple warnings and recalls for eye drops and related ophthalmic products. The primary reason: sterility failures, contamination, or insanitary manufacturing conditions. Because products applied to the eye bypass some natural defenses, contaminated drops can lead to eye infections, corneal damage, vision loss, and in rare cases death. The recalls have affected well-known store brands, artificial tears, and even millions of bottles distributed nationwide.
Consumers have been told to stop using certain products immediately. The recalls span from 2023 to 2026, with the largest involving more than 3 million bottles. This article provides a complete list of affected brands, explains why these recalls happened, and guides you on what to do if you have a recalled product.
Which Eye Drops Have Been Recalled? The Complete FDA List by Brand
Key dates: November 2023 (Leader brand), May 2025 (AvKare), April 2026 (3 million bottles).
Leader, AvKare, CVS Health, Rugby, Rite Aid, Target Up & Up, Velocity Pharma, and store brands sold by K.C. Pharmaceuticals.
Sterility concerns and manufacturing violations, including lack of assurance of sterility and insanitary conditions.
Check the FDA recall list, stop use, return product, and consult a doctor if symptoms occur.
- Multiple eye drop recalls have occurred over the past three years, indicating systemic manufacturing quality issues.
- The FDA is the authoritative source for recall information; consumers should rely on the official alerts.
- Recalls affect both store‑brand (Leader) and national brands (AvKare), with 3 million bottles recalled in 2026 alone.
- Public awareness and quick action are critical to prevent eye infections from non‑sterile products.
- Some recalled products have been linked to drug‑resistant bacteria, causing hospitalizations and vision loss.
- Not all eye drop brands are affected; consumers should verify specific products and lot numbers.
| Recall Date | Brand / Product | Reason | Number of Units | Source |
|---|---|---|---|---|
| November 2023 | Leader brand ophthalmic products (6 types) | Safety concerns – initiated by Cardinal Health | Not specified | FDA |
| May 2025 | AvKare brand eye drops (multiple types) | Sterility concerns from manufacturing violations | Not specified | AARP, Optometry Times |
| April 2026 | Eye drops sold at nationwide retailers (brands undisclosed) | Sterility issues – flagged by FDA | Over 3 million bottles | UC Davis Health |
What is the FDA eye drop recall list?
The FDA has issued multiple alerts since 2023. Key recalls include: Leader brand eye drops (Cardinal Health, Nov 2023), AvKare brand eye drops (May 2025), and over 3 million bottles from various brands distributed to retailers (April 2026). A full updated list is available on the FDA’s drug alerts page.
Are Systane eye drops recalled?
Based on current FDA alerts, Systane eye drops have not been explicitly listed in the major recalls. However, consumers should always verify with the official FDA list.
Are Refresh eye drops recalled?
Refresh eye drops are not mentioned in the recent FDA recall alerts. Check the FDA website for any updates.
Are AvKare eye drops recalled?
Yes. In May 2025, AvKare brand eye drops were voluntarily recalled due to sterility concerns from manufacturing violations, as reported by AARP and Optometry Times.
What about Maxitrol eye drops?
There is no current FDA recall for Maxitrol eye drops. However, always monitor the official recall list for changes.
Why Were These Eye Drops Recalled? Sterility and Safety Risks
What were the manufacturing violations?
The recalls were triggered by a lack of sterility assurance. For AvKare (2025), AARP reported violations in manufacturing processes that could compromise sterility. The 2026 recall of 3 million bottles was due to similar sterility concerns, as flagged by the FDA.
Using non‑sterile eye drops can lead to eye infections, which may cause vision loss or other serious health issues. The FDA warns consumers not to use affected products.
Are the recalled eye drops dangerous?
Yes. In 2023, EzriCare and Delsam Pharma artificial tears were linked to a drug‑resistant strain of Pseudomonas aeruginosa. The CDC reported hospitalizations, one death, and permanent vision loss. Contaminated drops can cause redness, burning, discharge, corneal ulcers, and systemic infection.
How Can I Check If My Eye Drops Are Part of the Recall?
How to check my eye drops for recall?
Locate the brand name, lot number, and NDC on the bottle. Compare against the FDA recall list published at fda.gov/drugs/drug-alerts-and-statements. You can also use the FDA’s recall lookup tool.
Check the bottle for product name, lot number, expiration date, and manufacturer. Then cross‑reference with the official FDA recall notice. If you are unsure, do not use the product.
Where can I find the complete FDA recall list?
Visit the official FDA drug alerts page. For the AvKare recall, refer to the AARP article. The UC Davis article lists the 2026 recall of 3 million bottles.
Can I return recalled eye drops?
Yes. Return them to the place of purchase for a refund. Do not throw them in the trash; follow local medical waste disposal guidelines.
What Should I Do If I Have Recalled Eye Drops?
What if I used recalled eye drops?
Contact your eye care provider if you experience redness, pain, discharge, or vision changes. The FDA advises to stop using the product immediately.
How to report adverse effects?
Report any side effects to the FDA’s MedWatch program at fda.gov/medwatch.
Stop using the product immediately. Wash your hands after handling. Seek urgent medical care if you have eye pain, swelling, light sensitivity, or blurred vision.
Are There Recent Recalls in 2025 and 2026? Timeline and Updates
- November 2023: Leader brand ophthalmic products (6 types) recalled by Cardinal Health due to safety concerns. FDA warning.
- May 2025: AvKare brand eye drops voluntarily recalled nationwide because of manufacturing sterility violations. AARP report.
- April 2026: FDA flags over 3 million bottles of eye drops sold at nationwide retailers due to sterility issues. Specific brand names have not been publicly released. UC Davis Health.
What Is Certain and What Is Still Unknown About the Recalls?
| Established Information | Information That Remains Unclear |
|---|---|
| The FDA has issued multiple recall alerts for eye drops since 2023. | The exact brands involved in the 2026 recall have not been publicly released yet. |
| AvKare eye drops were recalled in May 2025 due to sterility concerns. | Whether additional recalls beyond those listed are imminent. |
| Over 3 million bottles were recalled in April 2026. | The total number of manufacturers or products affected across all recalls. |
| Sterility concerns are the primary reason for the recalls. | How many consumers have been harmed by contaminated drops is not fully quantified. |
What Is the Context Behind These Recalls?
Eye drops are recalled when manufacturers fail to comply with current Good Manufacturing Practices (CGMP) for sterility. The FDA monitors production facilities and can request voluntary recalls if insanitary conditions or sterility failures are found. The 2026 recall of more than 3 million bottles is one of the largest in recent years, affecting store‑brand artificial tears and lubricant drops sold at national retailers. These events highlight ongoing challenges in maintaining sterile production across the ophthalmic industry.
Where Can I Find Official Sources and Expert Quotes?
“FDA warns consumers not to purchase or use certain eye drops… due to risk of eye infection.”
— FDA, official warning
“Over 3 million bottles of eye drops have been recalled.”
— UC Davis Health, April 2026 article
“Several types of AvKare brand eye drops are being recalled due to risks caused by manufacturing violations.”
— AARP, May 2025 report
“A voluntary product recall issued on May 12 stated several eye care products have been recalled nationwide due to potential safety risks.”
— Optometry Times, May 2025 article
Summary: What You Need to Know Now
Consumers should bookmark the FDA Drug Recalls: What You Need to Know guide, check their eye drop inventory against official recall notices, and consult an eye doctor if symptoms appear. Manufacturers may issue additional recalls if further violations are found. Staying informed through the FDA alerts page is the best way to protect your vision.
Frequently Asked Questions
How many eye drop recalls have there been?
At least three major recall events: November 2023 (Leader brand), May 2025 (AvKare), and April 2026 (3 million bottles).
Can recalled eye drops cause permanent damage?
Non‑sterile drops can cause eye infections that may lead to vision loss. Seek medical attention if you experience symptoms.
Are there any recalls for contact lens solution?
This article focuses on eye drops. Check the FDA alerts for contact lens solution recalls separately.
What does ‘voluntary recall’ mean?
The manufacturer chooses to remove the product from the market, often after FDA notification of a problem.
How often does the FDA update the recall list?
As new information becomes available. It is best to check the official FDA drug alerts page regularly.
Are all eye drop brands affected by the recall?
No. Only specific brands and lots listed in FDA alerts are affected. Always verify your product against the official list.
What should I do if I used recalled eye drops but have no symptoms?
Stop using the product and monitor for any eye discomfort. Consult a doctor if you have concerns.
Where can I report a problem with eye drops?
Report adverse events to the FDA MedWatch program at fda.gov/medwatch.
Can I get a refund for recalled eye drops?
Yes, return them to the place of purchase for a refund. Follow disposal instructions provided by the retailer.
Sophie Larkin is Music News Editor at PlaylisterUK.co.uk, covering artist announcements, releases, charts, labels, streaming platforms and the UK music industry.