More than 3 million eye drops are being recalled over fears they could be contaminated and harm vision.
Manufacturer K.C. Pharmaceuticals, based in California, issued the alert for its over-the-counter generic eye drop products due to a 'lack of assurance of sterility'.
It is not clear whether any are contaminated, but the FDA has said this is a Class II recall, meaning there is a temporary, and reversible, risk to the eyes and vision if the products are used.
The eye drops were sold nationwide in 0.5 fl oz bottles and were on shelves at CVS, Walgreens, Kroger, H-E-B and other stores.
They have a best-before date extending to May or October of this year.
No illnesses or injuries have been reported to date linked to the recall.
The FDA has not issued advice for consumers in relation to the warning. Consumers are typically told not to use the products and to throw them out immediately or return them to sellers for a full refund.
In 2023, a major eye drop recall was issued after drops made in India were found to be contaminated with a deadly bacteria. Overall, 81 patients were sickened, while 18 suffered permanent blindness and four died.
More than 3 million eyedrops have been recalled in the US because of a 'lack of assurance of sterility'.
The recall was revealed in an Enforcement Report on the FDA website. A press release has not been issued.
Drops in the alert were 1 million bottles of Dry Eye Relief Eye Drops; 590,000 bottles of Artificial Tears Sterile Lubricant Eye Drops; 378,000 bottles of Sterile Eye Drops Original Formula; 315,000 bottles of Sterile Eye Drops Redness Lubricant; 303,000 bottles of Eye Drops Advanced Relief; 245,000 bottles of Ultra Lubricating Eye Drops; 182,000 bottles of Sterile Eye Drops AC; and 74,000 bottles of Sterile Eye Drops Soothing Tears.
The lot codes for the products are available on the FDA website.
It was not clear how the issue with the product was caused, but it could have been because of improper hygiene standards at the manufacturing facility.
The recall was initiated on March 3 this year, and then given a classification on March 31.
Lack of assurance of sterility suggests that the drops may be contaminated with bacteria or particles that could damage the eye.
In the 2023 recall, the drops were contaminated with the bacteria Pseudomonas aeruginosa, which is resistant to standard antibiotics. It can infect the eye, leading to vision loss and, in extreme cases, it can spread to the blood and trigger the potentially fatal complication sepsis.
In January this year, Imprimis NJOF -- which claims to be America's largest ophthalmic pharmacy -- recalled nearly 2,000 boxes of prefilled syringes for treating eye infections because of the presence of 'glass-like particles'.
Warning signs of complications from eye drops include persistent redness, pain, abnormal yellow discharge, increased light sensitivity and blurred vision.
Doctors warn that anyone who is concerned they are suffering ill effects from the recalled eye drops should contact their doctor immediately.
Those who have sudden, severe or persistent eye pain, or sudden, severe changes in vision should also contact their doctor.
More than a third of Americans are estimated to use over-the-counter eye drops or eyewash.
The drops may be used to lubricate dry eyes, reduce redness or soothe irritation from environmental contaminants such as particles from smoke.