More than 3.1 million bottles of eye drops sold at major retailers have been recalled due to sterility concerns, according to a notice from the Food and Drug Administration. The products were distributed under multiple brand names and sold through national pharmacy chains and retail outlets.
Recall Initiated By Manufacturer And Classified As Class II
The recall was issued by K.C. Pharmaceuticals and announced in a March 3 alert. The affected products include Dry Eye Relief Eye Drops and Artificial Tears Sterile Lubricant Eye Drops, among others.
The FDA classified the recall as “Class II,” indicating that the products may cause temporary or medically reversible adverse health effects, with a low likelihood of serious consequences.
Products Sold Across Major Retail Chains
The recalled eye drops were sold at retailers including Walgreens, CVS, Kroger, Publix, Rite Aid, H-E-B, Harris Teeter, Meijer, Dollar General, and Circle K, as well as through pharmacy networks and military exchanges.
The largest single lot involved more than 1 million bottles of Dry Eye Relief Eye Drops.
Breakdown Of Affected Products And Volumes
The recall includes the following products and quantities:
- 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)
- 589,848 bottles of Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 fl. oz. (15 mL)
- 378,144 bottles of Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), 0.5 fl. oz. (15 mL)
- 315,144 bottles of Sterile Eye Drops Redness Lubricant (glycerin 0.25%, naphazoline HCl 0.012%), 0.5 fl. oz. (15 mL)
- 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)
- 245,184 bottles of Ultra Lubricating Eye Drops (polyethylene glycol 400 0.4%, propylene glycol 0.3%), 0.5 fl. oz. (15 mL)
- 182,424 bottles of Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL)
- 74,016 bottles of Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4%, propylene glycol 0.3%), 0.5 fl. oz. (15 mL)
Context Of Previous Eye Drop Recalls
The recall follows a separate incident in 2023 involving eye drops from a different manufacturer that were linked to bacterial contamination. The current recall centers on sterility concerns but does not specify contamination details.
Featured image credits: Opto-Mization
For more stories like it, click the +Follow button at the top of this page to follow us.