3.1 Million Bottles Of Eye Drops Recalled Over Serious Health Consequences

More than 3.1 million bottles of eye drops sold at several popular pharmacy stores have been recalled over concerns about their sterility, which has been reclassified as a Class II issue, the U.S. Food and Drug Administration announced in a notice.

Manufacturer K.C. Pharmaceuticals announced the initial recall on March 3 for products sold under eight brand names including Dry Eye Relief Eye Drops and Artificial Tears Sterile Lubricant Eye Drops, which account for more than 1 million and more than 500,000 of the recalled bottles, respectively. The recall was later classified by the FDA as a "Class II," which is designated when a product can potentially cause "temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."

The recalled items were sold at several major stores including Walgreens, CVS, Rite Aid, H-E-B and Harris Teeter. The K.C. Pharmaceuticals recalled products are listed 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.

A previous major eye drop recall took place in 2023 and involved Kilitch Healthcare India, which recalled numerous products over "safety concerns" after FDA investigators found unsanitary conditions at its production facility.