FDA Recalls Eye Drops from Walgreens, CVS Over Safety Concerns
A major voluntary recall has been issued for over 3 million eye drop products due to safety concerns. The Food and Drug Administration (FDA) raised issues regarding sterility assurance for these over-the-counter items. K.C. Pharmaceuticals, based in Pomona, California, is the manufacturer responsible for these products, which are marketed under various brand names.
Details of the Recall
The recall affects a total of 3,111,072 eye drop bottles, which began in early March 2023. These products can be found in major retail chains, including CVS, Walgreens, and Rite Aid.
FDA Classification
The FDA classified this as a “Class II recall.” This classification indicates that the products could potentially cause temporary health issues that are medically reversible. Users are advised that it is generally safe to continue using their eye drop medications during a Class II recall unless stated otherwise by the manufacturer.
Recalled Products
The following products are included in the recall:
- Sterile Eye Drops AC: Tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%, 0.5 fl oz (15 mL)
- EYE DROPS Advanced Relief: Dextran 70 0.1%, polyethylene glycol 400 1%, tetrahydrozoline HCl 0.05%, 0.5 fl oz (15 mL)
- Dry Eye Relief Eye Drops: Glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%, 0.5 fl oz (15 mL)
- Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4%, propylene glycol 0.3%, 0.5 fl oz (15 mL)
- Sterile Eye Drops Original Formula: Tetrahydrozoline HCl 0.05%, 0.5 fl oz (15 mL)
- Sterile Eye Drops Redness Lubricant: Glycerin 0.25%, naphazoline HCl 0.012%, 0.5 fl oz (15 mL)
- Sterile Eye Drops Soothing Tears: Polyethylene glycol 400 0.4%, propylene glycol 0.3%, 0.5 fl oz (15 mL)
- Artificial Tears Sterile Lubricant Eye Drops: Polyvinyl alcohol 0.5%, povidone 0.6%, 0.5 fl oz (15 mL)
As of now, there are no reported injuries related to the recalled eye drops. However, the specifics of what prompted the recall remain unclear, and K.C. Pharmaceuticals has not yet responded to media inquiries.
