Eye Drops Recall: What It Means, What to Keep and How California Law May Apply

What a recall means and what to do first

FDA's drug recalls page defines the term this way: "A recall is a voluntary action taken by a company to remove a defective drug from the market." The word "defective" is FDA's regulatory wording. It is not a court's decision about who is at fault for an injury.

A recall can start in more than one way. A company may begin one on its own, or FDA may recommend or request one. Either way, FDA oversees the company's recall plan.

FDA's eye drop guidance lists these first steps:

1. Stop using the drops if you have discharge, pain, changes in vision or discomfort.
2. Talk to a doctor.
3. Report the problem to FDA through its MedWatch program.
4. Check whether your drops are on a recall list.

If your eyes hurt, look red, have discharge or your vision has changed, see a doctor first.

If the drops may have hurt you, the checklist further down this page explains what to record before you return or throw anything away.

Why eye drops have to be sterile

Sterile means free of living germs. FDA's eye drop guidance is direct: "Any drug used in the eyes must be sterile to reduce the risk of infection." FDA explains that eye drops bypass some of the body's natural defenses.

Eye drops are sold two ways: by prescription, and over the counter (OTC). OTC means you can buy the medicine without a prescription.

FDA also reports that several recent OTC eye drop recalls followed safety concerns, including reports of infections, partial loss of vision and blindness. Those recalls were tied to contamination risks. FDA watches the market by inspecting factories, testing products and tracking reported side effects, and it may recommend voluntary recalls.

FDA's alerts have described recalled eye products as "intended to be sterile".

Eye drop recalls in FDA's public records

The records below come from FDA. Each describes a regulatory action, not a court finding that any company is legally responsible for an injury.

Store-brand drops from a California manufacturer (2026)

Two 2026 recall events in FDA's Enforcement Report cover OTC eye drops made by the same California manufacturer and distributed nationwide under many store and distributor labels. Every entry is Class II, and every entry gives the same reason: "Lack of Assurance of Sterility" (FDA Enforcement Report, event 98533; FDA Enforcement Report, event 99880).

• March 2026 recall (D-0409-2026 through D-0416-2026). Eight entries, started March 3, 2026 and classified March 31, 2026. They cover 15 mL bottles of artificial tears, dry eye relief, advanced relief, ultra lubricating, original formula (tetrahydrozoline), redness lubricant, AC (tetrahydrozoline and zinc sulfate) and soothing tears drops. The listed quantities add up to about 3.1 million bottles (FDA Enforcement Report, event 98533).
• September 2026 recall (D-0002-2027 through D-0009-2027). Eight entries, started September 11, 2026, classified October 5, 2026 and published in the Enforcement Report dated October 14, 2026. They cover artificial tears, dry eye relief, advanced relief, AC (tetrahydrozoline and zinc sulfate), original redness reliever, maximum redness relief, redness relief lubricant and high performance ultra lubricating drops. Seven of the eight entries list a quantity, and those add up to about 4.8 million cartons (FDA Enforcement Report, event 99880).

On August 12, 2026, FDA sent Warning Letter 320-26-112 to the manufacturer after inspecting its California plant in January and February 2026. FDA wrote that the company "continued to manufacture and release sterile drug products manufactured by aseptic processing" after failed media fills in 2024. Aseptic processing means filling a sterile product under germ-free conditions, without a final sterilizing step. A media fill is a test run that checks whether that filling process keeps germs out. FDA also cited "aseptic processing design deficiencies which pose significant hazards to drug product sterility." The letter describes a voluntary recall of all commercial products the company made between March 27 and November 7, 2024.

What these records do and do not say matters. "Lack of assurance of sterility" means the company could not show the drops were sterile. The records do not say germs were found in any bottle, and neither the Enforcement Report entries nor the Warning Letter reports an injury (FDA Enforcement Report, event 98533; FDA Warning Letter 320-26-112). These drops were sold under many store and distributor labels, so compare the product name, size, lot number and expiration date on your box with the FDA entries rather than relying on the store name.

An OTC lubricating eye gel (FDA Recall D-0491-2026)

FDA's Enforcement Report lists a voluntary, nationwide Class II recall of an OTC lubricating eye gel, FDA Recall D-0491-2026. The recall began on April 21, 2026. FDA classified it on April 24, 2026, and it appeared in the Enforcement Report dated May 6, 2026. The record listed the recall as ongoing when this page was prepared, so check the record for its current status.

The record gives this reason: "Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality." In plain words, the product could not be shown to be sterile. The record does not say that contamination was found.

Class II is FDA's middle recall class. FDA defines it as a recall where using the drug may cause temporary health consequences but the chance of a serious health problem is remote. The record does not report any injury.

One lot of single-use lubricant eye drop vials (December 2024)

On December 21, 2024, a company announced a nationwide recall of one lot of single-use lubricant eye drop vials. FDA posted the company's announcement on December 23, 2024. The company had received a complaint of foreign material inside a sealed vial and found the material was fungal. The product was sold through retail and internet outlets.

The announcement warned: "If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients." Immunocompromised means having a weakened immune system. The company reported no adverse events, meaning no reported injuries or side effects.

26 OTC eye products (October 2023)

In an October 2023 warning, FDA told consumers to stop using 26 OTC eye products intended to be sterile. FDA investigators had found insanitary (unclean) conditions and positive bacterial tests in critical production areas at the manufacturer. On October 25, 2023, FDA recommended that the manufacturer recall all lots. The list included store-brand drops sold by Target, and FDA later expanded it to add a Walmart store-brand drop. FDA recommended that consumers properly discard the listed products, and it said it had no reports of eye infections at that time.

Artificial tears recalled in February 2023

In February 2023, FDA recommended a recall of an OTC artificial tears product, and the company recalled all unexpired lots (FDA alert). FDA cited manufacturing violations including inadequate microbial testing, which checks for germs; multi-use bottles without an adequate preservative; and weak controls on tamper-evident packaging. FDA warned: "Using contaminated artificial tears increases risk of eye infections that could result in blindness or death." The injury section below describes a CDC outbreak investigation linked to artificial tears.

Unapproved and counterfeit eye products

In a September 2023 announcement, FDA said it had sent warning letters to eight firms marketing unapproved eye products for conditions such as pink eye, cataracts and glaucoma. Some letters also cited sterility problems. FDA warned that long-term use of drugs containing silver can turn skin and other tissue gray or blue-gray, a condition called argyria. FDA also warned that unapproved products claiming to treat serious eye conditions may lead people to delay or stop medical treatment.

In an October 2026 alert, FDA warned that counterfeit OTC eye drops had been found in Florida and Georgia, mainly in stores serving Spanish-speaking customers, and may be in other states. A counterfeit is a fake made to look like the real product. Several of these drops tested positive for bacteria. FDA said such drops may cause injury, infection or vision problems. At the time, FDA knew of no adverse events and was still investigating.

What recall classes mean, and how to check your drops

FDA sorts drug recalls into three classes based on health risk:

• Class I: a reasonable probability of serious health consequences.
• Class II: "Using the drug may cause temporary health consequences but the probability of a serious health issue is remote."
• Class III: not likely to cause health consequences.

The class describes FDA's view of the health risk. It does not decide whether a particular person was hurt or who is legally responsible.

FDA notes that not every recall is announced on its website or in the news. Its enforcement report database lists every recall, with its class and the reason for it.

To check your drops:

1. Find the lot number and expiration date printed on the box, bottle or vial.
2. Compare them with the recall notice or the FDA enforcement record.
3. If they match, stop using the product right away. If you were hurt, the checklist below explains what to record.
4. If you have symptoms, see a doctor whether or not your lot matches.

From factory to medicine cabinet: who makes and sells eye drops

The name on the box may not be the company that filled the bottle. The FDA records described on this page show several separate businesses between a factory and the person who buys the drops (FDA October 2023 warning; FDA Enforcement Report, event 99880).

Distributors and retailers

FDA's October 2023 warning shows where retailers fit. The recalled products included store-brand drops, and FDA reported that retailers including Target were removing them from shelves and websites. FDA later added a Walmart store-brand eye drop sold in stores and online, which Walmart was removing. Removing a product from shelves is a safety step, not a finding that the retailer is responsible for any injury. FDA's updates also describe recalls by distributors, the wholesale companies that move products from makers to sellers, as well as by the manufacturer. The 2026 recalls by the California manufacturer follow the same pattern: one manufacturer, many store labels (FDA Enforcement Report, event 99880).

Store and online sales

The December 2024 single-vial recall notice says that product was sold through retail and internet outlets. FDA's counterfeit alert shows that fake products can also reach buyers.

Each business plays a different role, and California law can reach more than one business in the chain of manufacture and sale, as the legal section below explains (Vandermark v. Ford Motor Co. (1964) 61 Cal.2d 256). If you were hurt, anything showing where and how you bought your drops may help answer later questions about who made and sold them.

Eye injuries reported in public health records

This section describes injuries that public health agencies have reported. Reading about them can be frightening, especially if you or someone close to you has been hurt.

A 2023 outbreak linked to artificial tears

As of May 15, 2023, the Centers for Disease Control and Prevention (CDC) outbreak investigation had found 81 patients identified with the outbreak strain in 18 states, including California. The strain is a drug-resistant form of the bacterium Pseudomonas aeruginosa, linked to artificial tears. Drug-resistant means common antibiotics may not work against it. Outcomes included 14 patients with vision loss, four more patients who had an eye surgically removed, and four deaths within 30 days of a culture being collected.

CDC reported that the outbreak strain was found in opened bottles, and FDA found bacterial contamination in unopened bottles. The product patients reported most often was a preservative-free OTC artificial tear sold in multidose bottles, meaning bottles meant to be used many times. That product was the artificial tears recalled in February 2023.

Symptoms CDC listed in this outbreak included:

• discharge from the eye
• eye pain or discomfort
• redness
• a feeling that something is in the eye
• sensitivity to light
• blurry vision

These symptoms may have many causes. Only a doctor can tell you what is happening in your eye.

Risks described in FDA and company records

• Partial vision loss or blindness, in FDA's October 2023 warning
• Blindness or death from contaminated artificial tears, in FDA's 2023 artificial tears alert
• Infection that may threaten vision, and in very rare cases may threaten the life of someone with a weakened immune system, in the company's December 2024 recall notice
• Gray or blue-gray discoloration of skin and tissue from silver in unapproved products, in FDA's September 2023 announcement

Many recalls report no injuries. The December 2024 single-vial recall reported no adverse events. FDA's October 2023 warning said FDA had no reports of eye infections at that time. FDA's October 2026 counterfeit alert said it knew of no adverse events. A recall does not mean your drops hurt you.

See a doctor if you have symptoms

If you used recalled or suspect drops and have any of these symptoms, contact an eye doctor or urgent care promptly. Bring the box, or a photo of the label and lot number, with you. FDA also asks people to report problems through MedWatch (FDA eye drop guidance).

What to record if eye drops may have hurt you

Your health comes first. Stop using the drops and get medical care if you have symptoms. Then record what you can:

1. Photos of the bottle, vials or tube and the outer box, showing the product name, lot number and expiration date.
2. The paper insert and the box, if you still have them. The lot number and expiration date are usually printed there.
3. Proof of purchase: your receipt, order confirmation, pharmacy label or a card statement showing the purchase.
4. Your medical records: the names of every doctor or clinic you saw, visit dates, test results and prescriptions.
5. A copy or screenshot of the recall notice or FDA record that matches your product.

Before you return anything

FDA and recall notices tell consumers to stop using recalled drops and explain what to do with them. FDA's October 2023 warning recommended that consumers properly discard the listed products, and the December 2024 notice told consumers to return the product to the place of purchase.

Follow those safety instructions, and get medical care first if you have symptoms. Before you discard or return the drops, record the lot number, expiration date and label. If you were injured and it is safe to do so, you can ask a lawyer promptly whether the product should be kept, because testing it can sometimes matter, but never delay medical care for that. Never use the drops again, and keep them where no one else can use them.

You can report the problem to FDA through MedWatch (FDA eye drop guidance).

H Law Group's guide to preserving evidence after a product injury explains in more detail why the product matters.

When the cause becomes clear later

A link between a product and an injury may not be apparent right away. In the 2023 outbreak, CDC reported that six of the 13 most recently added patients had samples collected before the February 2, 2023 recall, and that those cases were confirmed afterward because testing takes time (CDC, as of May 15, 2023).

The legal section below explains how California's discovery rule works. It can delay the start of a filing deadline, but it can also start the clock once a person suspects wrongdoing. H Law Group's article on California filing deadlines for injury claims explains more.

How California product liability law may apply

A recall is a regulatory step that a company takes with FDA oversight. Whether any company is legally responsible for an injury is a separate question that turns on the facts and on California law.

Strict liability for the maker

California applies strict product liability. In Greenman v. Yuba Power Products, Inc. (1963) 59 Cal.2d 57, the California Supreme Court held: "A manufacturer is strictly liable in tort when an article he places on the market, knowing that it is to be used without inspection for defects, proves to have a defect that causes injury to a human being." Strict liability means an injured person does not have to prove the company was careless. The person still has to show that the product was defective and that the defect caused the injury. H Law Group's article on strict liability explains the doctrine in more detail.

This framework can matter for eye drops, because people put them directly into their eyes without any way to inspect them for germs, and FDA says any drug used in the eyes must be sterile.

The chain of distribution

California's rule does not stop at the factory. In Vandermark v. Ford Motor Co. (1964) 61 Cal.2d 256, the Supreme Court held a retailer strictly liable for injuries caused by a defect in a product it sold, describing retailers as "an integral part of the overall producing and marketing enterprise." For eye drops, that matters because the company that filled the bottle, the company whose label is on the box and the store that sold it may be different businesses, as the section above shows. Which of them may be responsible in a given case depends on the evidence.

What a recall proves and what it does not

A recall shows that a company, with FDA oversight, took a product off the market. It is not, by itself, proof that a particular bottle was defective or that it caused a particular injury. A "lack of assurance of sterility" recall, like the 2026 recalls by the California manufacturer, does not say germs were found (FDA Enforcement Report, event 99880). Under California's jury instructions, a product has a manufacturing defect if it "differs from the manufacturer's design or specifications or from other typical units of the same product line" (CACI No. 1202). When contamination results from the manufacturing or aseptic-production process, it may support a manufacturing-defect theory. H Law Group explains the three defect types in what makes a product legally defective. The product, its lot number, medical records and, in some cases, laboratory testing are what connect a recall to an injury. That is why the checklist above matters.

When the clock starts: the discovery rule

The deadlines section on this page explains California's general filing deadlines for injury claims (Code of Civil Procedure section 335.1). When a deadline begins can depend on the facts. Under the discovery rule in Jolly v. Eli Lilly & Co. (1988) 44 Cal.3d 1103, the period begins when a person "suspects or should suspect that her injury was caused by wrongdoing." That rule cuts both ways. It can delay the start of the period for someone who had no reason to suspect the drops played a role until later. But once a person suspects wrongdoing, "she cannot wait for the facts to find her." When that point arrives depends on the facts of each case, so do not wait to get advice.

Prescription drops

FDA treats prescription and OTC eye drops as separate categories (FDA eye drop guidance). Claims about prescription eye drops can raise different legal questions than claims about OTC drops. In Brown v. Superior Court (1988) 44 Cal.3d 1049, the California Supreme Court held that a prescription drug maker is not strictly liable for injuries from a drug that was "properly prepared and accompanied by warnings of its dangerous propensities." The court noted that drug makers remain subject to liability for manufacturing defects. Brown concerned prescription drugs. It does not decide claims about over-the-counter drops, and prescription-drug claims can raise other questions, including federal law issues, that this page does not cover.

H Law Group's page on dangerous drug claims covers injuries from prescription and OTC medicines, including contaminated drugs. Its overview of compensation in a California injury claim describes the kinds of losses an injury claim can address.

For the elements a manufacturing-defect claim must prove and how recall records fit in, see what an eye drop recall lawsuit must prove in California.

Reporting a problem and finding more help

FDA asks consumers to report eye drop problems through its MedWatch program. FDA's eye drop guidance also lists its past eye drop alerts, which can help you check a product you have at home.

H Law Group's guide to reporting dangerous products to the right federal agency explains where different kinds of reports go.

If you have questions about a recalled eye product and an injury, you can reach H Law Group through the contact form on this page.