FDA recalls steroid eye drops nationwide

The U.S. Food and Drug Administration said in a July 10 enforcement report that millions of bottles of a prescription steroid eye drop were recalled nationwide because of possible contamination by “a foreign substance.” The product identified in the report was prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, a sterile, prescription-only ophthalmic drug. Ophthalmology Times reported the recall on July 10, citing the FDA enforcement report. ### Which eye drop was recalled? The FDA enforcement report identified the recalled product as prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, sold in 5 mL, 10 mL and 15 mL bottles. The Ophthalmology Times report listed the product as sterile and prescription-only, and included the National Drug Code numbers tied to the three bottle sizes. (ophthalmologytimes.com) A separate industry report said more than 2.5 million bottles were covered by the action and named Lupin Limited as the manufacturer and Lupin Pharmaceuticals Inc. as the U.S. distributor. That report said the recall was voluntary and nationwide. ### Why did the FDA say it was recalled? The FDA report said the reason for the recall was the potential presence of “a foreign substance” in the eye drops. (ophthalmologytimes.com) Ophthalmology Times, citing the same enforcement report, described the action as a nationwide recall of millions of bottles for that contamination concern. The FDA says eye drops carry a heightened risk because drugs applied to the eye bypass some of the body’s natural defenses, and any drug used in the eyes must be sterile to reduce the risk of infection. (glance.eyesoneyecare.com) The agency says contamination risks in ophthalmic products have been linked in past recalls to infections, vision loss and blindness. ### What kind of drug is prednisolone acetate? (ophthalmologytimes.com) Prednisolone acetate ophthalmic suspension is a steroid eye drop used to treat eye inflammation. Cleveland Clinic’s drug description, cited in secondary coverage of the recall, says prednisolone treats eye swelling, redness or itching caused by infections, injury or other conditions. FDA labeling for prednisolone acetate ophthalmic suspension describes it as a sterile topical anti-inflammatory agent for ophthalmic use. (fda.gov) The agency’s consumer guidance says ophthalmic products require particular care because contamination can pose direct risk to the eye. ### How does an FDA drug recall work? The FDA says a drug recall is generally a voluntary action taken by a company to remove a defective drug from the market or warn patients and consumers about a potential risk. (newsnationnow.com) The agency maintains a drug recalls database and says recalls not marked as terminated are either ongoing or completed. The FDA’s enforcement reports page says the weekly report includes recalls monitored by the agency, including products that may be Class I, II, III or not yet classified. (accessdata.fda.gov) Secondary coverage of this case said the prednisolone acetate recall was classified by the FDA as a Class II recall on June 30, 2026. ### What should patients and clinicians check now? The FDA says consumers should stop using eye drops if they experience discharge, eye pain, vision changes or discomfort and should contact a doctor and report unexpected side effects to the agency. (fda.gov) The agency also advises users not to touch the bottle tip to the eye, hands, clothing or other surfaces to avoid contamination. (fda.gov) The FDA’s drug recalls page and enforcement reports remain the primary public sources for checking whether a recall is ongoing, terminated or expanded. Ophthalmology Times published the affected product description on July 10, and the FDA database carries the agency’s current recall listings. (ophthalmologytimes.com) (fda.gov)