Key keywords: FDA eye drop recall, foreign substance contamination, over-the-counter ophthalmic products, public health safety alert, eye infection risk, voluntary product recall, contaminated eye care supplies, adverse event reporting The U.S. Food and Drug Administration (FDA) issued a formal public safety announcement on October 12, 2024, declaring a nationwide voluntary recall of 31 batches of over-the-counter (OTC) eye drop products from 6 mainstream consumer brands, including popular artificial tears, redness relief drops, and allergy eye drops, after routine quality sampling detected unapproved foreign substances in multiple product samples. Laboratory analysis confirmed the foreign substances include micro-sized plastic particulate matter and traces of non-sterile fungal spores, which entered the products during the manufacturing and bottling process at two contract production facilities located in Ohio and Florida. Neither of the facilities had reported process breaches to the FDA prior to the sampling results, prompting the agency to launch a full investigation into the two sites’ quality control protocols. The FDA warned that exposure to the contaminated eye drops could carry a range of health risks, from mild symptoms such as eye stinging, redness, blurred vision, and persistent irritation, to severe adverse events including bacterial or fungal corneal ulcers, interior eye infection, and even permanent vision loss for high-risk groups, including contact lens wearers, people with compromised immune systems, and patients who have recently undergone eye surgery. As of the announcement date, the FDA has received 17 reports of adverse reactions linked to the recalled products, with 3 patients requiring outpatient treatment for eye infections, though no cases of permanent vision damage have been confirmed to date. Consumers are urged to immediately check the lot numbers and UPC codes of any eye drop products they have purchased in the past 3 months against the full recall list published on the FDA’s official website. All affected products should be disposed of safely or returned to the original place of purchase for a full refund, regardless of whether they have been opened. Anyone who has used the recalled products and is experiencing unusual eye symptoms is advised to seek medical attention as soon as possible, and to report their condition to the FDA’s MedWatch Adverse Event Reporting System to support ongoing monitoring. This recall marks the third major OTC eye product safety incident in the U.S. since 2023, prompting consumer advocacy groups to call for stricter regular testing requirements for ophthalmic products sold over the counter, to prevent similar contamination risks from reaching the public. The FDA noted that it will release updated findings from its investigation into the two manufacturing facilities within 30 days, and will consider imposing additional regulatory penalties if significant violations of good manufacturing practices are confirmed.