Over 3 Million Eye Drops Recalled Over Sterility Concerns

More than 3.1 million bottles of over-the-counter eye drops have been voluntarily recalled by K.C. Pharmaceuticals due to concerns about their sterility, the Food and Drug Administration announced in early March. The recall affects products sold under multiple brand names, including Dry Eye Relief Eye Drops, Artificial Tears Sterile Lubricant Eye Drops, and various Sterile Eye Drops formulas. These products were distributed through major retailers such as Walgreens, CVS, Rite Aid, Kroger, Publix, and others.

The FDA classified the recall as Class II, indicating that the products may cause temporary or medically reversible adverse health effects, but the likelihood of serious consequences is remote. To date, there have been no reported injuries linked to the recalled eye drops. The FDA advises consumers that they may continue using the products unless otherwise directed by the company.

The recall involves eight specific product lines with a total of 3,111,072 bottles. The largest quantity recalled is 1,023,096 bottles of Dry Eye Relief Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), sold at stores including Rite Aid, H-E-B, Meijer, Harris Teeter, and military exchanges. Other recalled products include:

• 589,848 bottles of Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), sold at Kroger, Publix, Leader, TopCare, Good Neighbor Pharmacy, and Good Sense.
• 378,144 bottles of Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), available 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, Equaline, and 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 FDA notice did not specify what triggered the recall, and K.C. Pharmaceuticals did not immediately respond to requests for comment. Consumers who have purchased these products are advised to check lot numbers and consult the FDA website or their retailers for guidance on returns or replacements.