Sterility issues prompt nationwide recall of 3 million eye drop bottles

Millions of bottles of eye drops have been recalled due to sterility issues.

The Food and Drug Administration announced the nationwide recall of the eye drops made by K.C. Pharmaceuticals. The company voluntarily recalled the products.

The initial recall was issued on March 3, but it was classified as a Class II recall on March 31.

A Class II recall is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” the FDA said.

In all, 3,111,072 bottles were recalled, sold under brands or at stores such as Top Care, Meijer, H-E-B, Walgreens, CVS, Kroger, Rite Aid, Harris Teeter and others.

The following types of eye drops were recalled:

Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles (182,424 bottles)
EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile (303,216 bottles)
Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles (1,023,096 bottles)
Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles (245,184 bottles)
Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles (378,144 bottles)
Sterile Eye Drops Redness Lubricant (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles (315,144 bottles)
Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles (74,016 bottles)
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles (589,848 bottles)

Click here to see the entire list of retailers, brands, UPC numbers and lot codes involved in this recall.