The U.S. Food and Drug Administration announced a nationwide recall of multiple over-the-counter eye drop products due to a lack of assurance of sterility.
The recall, initiated March 3 by K.C. Pharmaceuticals Inc. of Pomona, California, affects products distributed nationwide in the United States. The recall was classified as Class II on March 31.
According to the FDA, the recall involves more than 3 million bottles of eye drops sold under a variety of brand names and store labels, including Walgreens, CVS, Kroger, Rite Aid and others.
The recalled products are:
See the full list of affected products here.
- Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl oz (15 mL) bottles
- Eye Drops Advanced Relief (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 fl oz (15 mL) bottles
- Dry Eye Relief Eye Drops (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%), 0.5 fl oz (15 mL) bottles
- Ultra Lubricating Eye Drops (polyethylene glycol 400 0.4%, propylene glycol 0.3%), 0.5 fl oz (15 mL) bottles
- Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), 0.5 fl oz (15 mL) bottles
- Sterile Eye Drops Redness Lubricant (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles
- Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 fl oz (15 mL) bottles
- Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 fl oz (15 mL) bottles
The products include multiple lot numbers with expiration dates ranging from April through October 2026.
The FDA said the recall was issued due to a lack of assurance of sterility, which could pose a risk to consumers. A Class II recall indicates that use of the product may cause temporary or medically reversible adverse health consequences.
The recall remains ongoing. Consumers are advised to check their products and not use any affected eye drops.
