Eye Drop Recall Lawsuit: What You Must Prove in California

What the recall records show, and what they do not

On October 5, 2026, FDA classified a Class II recall covering eight eye drop products, recall numbers D-0002-2027 through D-0009-2027. The products are lubricant, artificial tears, dry eye and redness relief drops made by a California manufacturer and sold under many distributor and store labels. Seven of the eight entries list a quantity, and those add up to about 4.8 million cartons. Two months earlier, FDA's Warning Letter 320-26-112 said 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.

Records like these may help show that a problem existed in how products were made. They do not by themselves prove that a particular bottle was defective or that it caused a particular injury. A "lack of assurance of sterility" recall means the maker could not show the drops were sterile, and FDA's records on these recalls do not report confirmed contamination or any injury (FDA Enforcement Report, event 99880; FDA Warning Letter 320-26-112). H Law Group's page on dangerous drug claims covers injuries from contaminated over-the-counter medicines.

For the full list of eye drop recalls in FDA's public records and how to check your drops, see H Law Group's eye drops recall overview.

What you must prove in California

California applies strict product liability. In Greenman v. Yuba Power Products, Inc. (1963) 59 Cal.2d 57, the California Supreme Court held that a manufacturer is strictly liable "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." You do not have to prove the company was careless. For a strict-liability manufacturing-defect claim, California's civil jury instructions list four elements (CACI No. 1201):

1. Who made or sold it. The company manufactured, distributed or sold the drops.
2. A defect when it left the company. The drops contained a manufacturing defect when they left that company's possession.
3. Harm. You were harmed, such as by an eye infection or vision loss. Medical records help show this.
4. Causation. The defect was a substantial factor in causing your harm.

Under CACI No. 1202, 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." 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.

These four elements apply to a manufacturing-defect claim only. Other theories, such as design defect, failure to warn and negligence, are separate claims with their own elements in California's jury instructions (CACI Series 1200). Which theories fit depends on the facts.

Prescription drops can raise different questions. 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 a drug that was "properly prepared and accompanied by warnings of its dangerous propensities," while noting that drug makers remain subject to liability for manufacturing defects. That case concerned prescription drugs. It does not decide claims about over-the-counter drops.

Connecting the drops to your injury

Causation can be the hardest part of an eye drop claim. Evidence that can help includes the product and its lot number, where and when you bought it, when you used it, when symptoms began, and what your doctors found, including any lab tests.

Public health records show that the link between drops and an infection can take time to confirm. In a separate 2023 outbreak, tied mainly to an artificial tears product recalled in February 2023 and not to the 2026 drops described above, CDC reported 81 patients identified with the outbreak strain, a drug-resistant bacterium, in 18 states including California, as of May 15, 2023. Fourteen had vision loss, and four more had an eye surgically removed. Some cases were confirmed after that recall, partly because testing takes time. The other recall records on this page reported no injuries when they were issued.

CDC lists these signs, which may indicate an eye infection; a doctor can confirm:

• Yellow, green or clear discharge
• Eye pain or redness
• Feeling that something is in the eye
• Light sensitivity or blurry vision

Who may be responsible

The name on the shelf may not be the maker. The 2023 Target and Walmart store-brand drops in FDA's October 2023 warning came from an outside manufacturer, and the 2026 recalls covered many distributor and store labels from one manufacturer (FDA Enforcement Report). Being named in an FDA warning or removing a product from shelves is not a finding that a retailer is responsible for any injury. In Vandermark v. Ford Motor Co. (1964) 61 Cal.2d 256, the California Supreme Court held a retailer strictly liable for a defect in a product it sold, calling retailers "an integral part of the overall producing and marketing enterprise." Which businesses may be responsible depends on the evidence. Learn how California strict liability works.

When the clock starts

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 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 can delay the start 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. See California filing deadlines for injury claims.

What to do and what to record

1. Stop using the drops right away and see a doctor if you have symptoms. Medical care comes first. FDA warnings and recall notices tell consumers to stop using recalled products (for example, FDA's October 2023 warning and a December 2024 recall notice).
2. Report the problem to FDA's MedWatch program, as the December 2024 recall notice describes, and keep a copy.
3. Write down or photograph the lot number, expiration date and label on the box and bottle.
4. Follow FDA and recall-notice safety instructions, which may tell you to discard or return recalled drops. Record the details above before you do. If you were injured and it is safe to do so, you can ask a lawyer promptly whether the product should be kept, but never delay medical care for that. Never use the drops again, and keep them where no one else can use them.
5. Keep the receipt or online order showing where you bought them.
6. Keep medical records from every eye visit.

See what evidence to keep after a product injury and what compensation a California injury claim can address.