More than 3 million bottles of eye drops sold at CVS, HEB, Kroger, Meijer, Walgreens and other stores nationwide have been voluntarily recalled due to a "lack of assurance of sterility," according to anoticefrom the U.S. Food and Drug Administration.
The recalled eye drops were produced by KC Pharmaceuticals Inc., a private label maker, and were sold under multiple brand names, including Best Choice, CVS, Discount Drug Mart, Gericare, Kroger and Walgreens.
The drops were initially recalled on March 3, according to the FDA.
On March 31, the FDA assigned the recall a Class II designation,definedby the agency as a recall in which use of the affected product may cause "temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
Voluntary recall issued for eye drops sold nationwide
The recall impacts 3,111,072 bottles of eye drops with the following labels:
182,424 bottles of Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5-ounce (15-milliliter) bottles
303,216 bottles of Eye Drops Advanced Relief (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5-ounce (15-milliliter) bottles, sterile
1,023,096 bottles of Dry Eye Relief Eye Drops (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%), 0.5-ounce (15-milliliter) bottles
245,184 bottles of Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), sterile, 0.5-ounce (15-milliliter) bottles
378,144 bottles of Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), 0.5-ounce (15-milliliter) bottles
315,144 bottles of Sterile Eye Drops Redness Lubricant (glycerin 0.25% and naphazoline HCl 0.012%), 0.5-ounce (15-milliliter) bottles
74,016 bottles of Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5-ounce (15-milliliter) bottles
589,848 bottles of Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5-ounce (15-milliliter) bottles
A full list of recalled eye drops and their brand names, lot numbers, UPC codes and expiration dates can be found on theFDA website.
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CVS shared several recall notices on its website forGeriCare Artificial Tears Lubricant Eye Drops,CVS Lubricant Eye Drops Redness Reliever, CVS Lubricant Eye Drops Dry Eye, and two-packs of CVS Lubricant Eye Drops Redness Reliever, citing potential microbial contamination.
In a statement to ABC News on Friday, a CVS spokesperson said the four products were "discontinued nearly a year ago," and that the company was "fully cooperating" with the manufacturer recall.
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"We're committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers' needs," the spokesperson said.
Customers who purchased the products may return it to any CVS Pharmacy for a refund, they added.
ABC News has reached out to KC Pharmaceuticals Inc. for comment.
Editor's note: This article has been updated to include new comments from a CVS spokesperson.