The U.S. Food and Drug Administration recalled 747,844 units of eye drops and related eye products sold under nine brand names because they may not be sterile. Consumers who bought the affected products should check the lot number and stop using any product included in the recall.
The products were made by Sterling Pharmaceutical Services in Dupo, Illinois, and include lubricant eye drops, lubricating tears, an eye solution and an ointment. The FDA said products in the Class II recall may cause temporary or medically reversible adverse health consequences, while the probability of serious adverse health consequences is remote.
Aug. 20 recall
The initial eye drop recall was issued on Aug. 20, then upgraded to a Class II recall on Sept. 21. That classification gives consumers a clearer read on the risk level: the products may cause harm, but the FDA said serious outcomes are remote.
For readers checking their cabinets, the practical step is simple. Match the lot number on the package against the recall list, and if the product is included, stop using it immediately. The recall covers products sold under nine different brand names, but the notice does not list those names in the facts provided here.
Rohto and Clear Eyes
The current recall sits alongside earlier eye-drop actions this year. On Aug. 1, nearly 12 million bottles of Rohto eye drops were recalled over sterility concerns, in a voluntary action by Rohto-Mentholatum, and on Aug. 20 nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief were recalled because of potential contamination. A separate Clear Eyes recall report tracked one of those earlier actions.
Those earlier recalls show why lot checks matter. Eye drop packaging can look identical on a shelf while only certain batches are affected, so the lot number is the deciding detail for anyone deciding whether a bottle belongs in the recall.
Sterility and risk
The complication in this case is the FDA's own risk call: the products may not be sterile, yet the agency said the probability of serious adverse health consequences is remote. That leaves consumers with a product they should not keep using, even though the agency did not describe the recall as likely to produce severe harm.
The immediate next step for anyone with one of the products is to identify the lot number before using it again. The recall notice does not provide the full nine-brand list here, so the lot number remains the most important check for consumers.
