More than 3 million eye drops are being recalled due to concerns over potential contamination that could harm vision. The recall was initiated by K.C. Pharmaceuticals, a company based in California, which issued an alert for its over-the-counter generic eye drop products. The reason for the recall is a ‘lack of assurance of sterility’, which means the products may not meet the required hygiene standards.
Although it is not yet clear whether any of the products are actually contaminated, the U.S. Food and Drug Administration (FDA) has classified this as a Class II recall. This type of recall indicates a temporary and reversible risk to the eyes and vision if the products are used. The affected eye drops were sold nationwide in 0.5 fl oz bottles and were available at major retailers such as CVS, Walgreens, Kroger, H-E-B, and others.
The products have a best-before date extending to May or October of this year. To date, no illnesses or injuries have been reported in connection with the recall. The FDA has not provided specific guidance to consumers, but typically advises people not to use the products and to dispose of them immediately or return them to the seller for a full refund.
This recall comes after a similar incident in 2023, when a major eye drop recall was issued following the discovery of contamination with a deadly bacteria. In that case, 81 patients were sickened, 18 suffered permanent blindness, and four people died. The contamination involved eye drops made in India, which were found to be contaminated with Pseudomonas aeruginosa, a bacterium resistant to standard antibiotics. This type of infection can lead to vision loss and, in severe cases, sepsis.
The current recall was detailed in an Enforcement Report on the FDA website, though no press release has been issued. The affected products include:
- 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
- 74,000 bottles of Sterile Eye Drops Soothing Tears
The lot codes for these products are available on the FDA website. It is unclear how the issue occurred, but it may have been due to improper hygiene standards at the manufacturing facility. The recall was first initiated on March 3 this year and received its classification on March 31.
A 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 contamination led to serious health complications, including vision loss and sepsis.
In January this year, another recall was issued by Imprimis NJOF, which claims to be America’s largest ophthalmic pharmacy. Nearly 2,000 boxes of prefilled syringes for treating eye infections were recalled due to the presence of ‘glass-like particles’.
Consumers should be aware of warning signs of complications from eye drops, such as persistent redness, pain, abnormal yellow discharge, increased light sensitivity, and blurred vision. Doctors advise that anyone experiencing these symptoms should contact their doctor immediately. Those who experience sudden, severe, or persistent eye pain, or sudden, severe changes in vision, should also seek medical attention.
More than a third of Americans are estimated to use over-the-counter eye drops or eyewash. These products are commonly used to lubricate dry eyes, reduce redness, or soothe irritation caused by environmental contaminants such as smoke particles.
