Over 3.1 million eye drop bottles recalled due to sterility concerns

More than 3.1 million bottles of eye drops sold at major retailers nationwide are being recalled over concerns about their sterility, the Food and Drug Administration said.

K.C. Pharmaceuticals, Inc., a Pomona, California-based manufacturer, voluntarily initiated the recall on March 3, with the FDA classifying it on Tuesday. The products were distributed through chains including Walgreens, CVS, Kroger, Rite Aid, H-E-B, Publix, Meijer, Harris Teeter, Dollar General and military exchanges, among others.

The FDA assigned the recall a “Class II” classification, meaning exposure to the affected products may cause temporary or medically reversible adverse health consequences, with the probability of serious harm considered remote.

Eight product lines are affected, spanning more than 3.1 million bottles in total:

• 1,023,096 bottles of Dry Eye Relief Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%) — sold at Rite Aid, H-E-B, Meijer, Harris Teeter and military exchanges
• 589,848 bottles of Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%) — sold at Kroger, Publix, Leader and TopCare, and through Good Neighbor Pharmacy and Good Sense
• 378,144 bottles of Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%) — sold at 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%) — sold at Walgreens, Rite Aid, Leader and Equaline, and through workplace distributor Cintas
• 303,216 bottles of Eye Drops Advanced Relief (dextran 70 0.1%, polyethylene glycol 400 1%, tetrahydrozoline HCl 0.05%) — sold at Walgreens, Kroger and CVS
• 245,184 bottles of Ultra Lubricating Eye Drops (polyethylene glycol 400 0.4%, propylene glycol 0.3%) — sold at Leader and Harris Teeter
• 182,424 bottles of Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%) — sold at Walgreens, Meijer and H-E-B
• 74,016 bottles of Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4%, propylene glycol 0.3%) — sold at Walgreens and through Rugby Laboratories

The recall is among the latest in a series of eye drop safety alerts in recent years. A separate recall earlier this year was triggered by the presence of glass-like particles in certain products. A 2023 recall involved a different manufacturer whose drops were found to potentially contain bacteria.

Consumers who purchased any of the affected products can find specific lot codes and UPC information in the FDA’s enforcement report.