More than 12 million bottles of over-the-counter eye drops have been recalled nationwide for failing to meet safety standards, according to a report from the Food and Drug Administration (FDA).
Several types of Rohto-brand eye drops were recalled under a class II FDA standard, meaning the products may cause temporary effects but are not likely to result in serious health complications. An enforcement report from the agency lists 11,960,623 cartons of eye drops, containing 12,460,649 bottles, as having a "lack of assurance of sterility," meaning the bottles could have lost the sterile properties that prevent germ contamination and infection.
The recall was first initiated on July 14 by Rohto-Mentholatum, which manufactures the medication in Vietnam
and distributes it through the New York-based Mentholatum Company.
USA TODAY has reached out to Mentholatum for comment. Here's what to know.
Which bottles of eye drops are being recalled?
Eight different types of Rohto eye drops are subject to the recall. The medication was sold over-the-counter nationwide, according to the FDA.
What to do if you have the recalled eye drops
Consumers should not use recalled eye drops, as they could be contaminated or cause infection. While the FDA did not specify in the enforcement report, recalled products can often be returned to the place of purchase; call your local store to check your options.
If you are concerned about potential health effects, contact your doctor.
This article originally appeared on USA TODAY: Millions of eye drops recalled. See list of affected products
