More than 3.1 million bottles of eye drops sold at major retailers, including Walgreens and CVS, are being recalled due to concerns about their sterility, according to a notice from the Food and Drug Administration.
The eyedrops have been recalled by their manufacturer, K.C. Pharmaceuticals, according to the March 3 alert. The products were sold under a number of brand names, including Dry Eye Relief Eye Drops and Artificial Tears Sterile Lubricant Eye Drops.
The recall was classified as “Class II” by the FDA, which describes products that may cause “temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” Another major eye drops recall in 2023 involved a different manufacturer whose products may have contained bacteria.
The latest eye drops recall involves eight brands manufactured by K.C. Pharmaceuticals, with the largest lot involving more than 1 million bottles sold under the Dry Eye Relief Eye Drops brand at stores including Rite Aid, H-E-B and Harris Teeter.
The recalled items are below:
- 1,023,096 bottles of Dry Eye Relief Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 fl. oz. (15 mL): Sold at stores including Rite Aid, H-E-B, Meijer and Harris Teeter, as well as military exchanges.
- 589,848 bottles of Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 fl. oz. (15 mL): Sold at stores including Kroger, Publix, Leader and TopCare, as well as through Good Neighbor Pharmacy and Good Sense.
- 378,144 bottles of Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), 0.5 fl. oz. (15 mL): Sold at stores including Walgreens, Kroger, CVS, H-E-B, Harris Teeter, Dollar General, Circle K and Leader.
- 315,144 bottles of Sterile Eye Drops Redness Lubricant (glycerin 0.25%, naphazoline HCl 0.012%), 0.5 fl. oz. (15 mL): Sold at stores including Walgreens, Rite Aid, Leader and Equaline, as well as workplace distributor Cintas.
- 303,216 bottles of Eye Drops Advanced Relief (dextran 70 0.1%, polyethylene glycol 400 1%, tetrahydrozoline HCl 0.05%), 0.5 fl. oz. (15 mL): Sold at stores including Walgreens, Kroger and CVS.
- 245,184 bottles of Ultra Lubricating Eye Drops (polyethylene glycol 400 0.4%, propylene glycol 0.3%), 0.5 fl. oz. (15 mL): Sold at stores including Leader and Harris Teeter.
- 182,424 bottles of Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL): Sold at stores including Walgreens, Meijer and H-E-B.
- 74,016 bottles of Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4%, propylene glycol 0.3%), 0.5 fl. oz. (15 mL): Sold at Walgreens and through Rugby Laboratories.