The FDA has issued a voluntary recall of over 3.1 million bottles of eye drops sold at multiple store brand locations across the United States.
The reason: “A lack of assurance of sterility.”
First things first: Which products are these?
Eight different eye drop brands are included in the recall—all manufactured by the same company: K.C. Pharmaceuticals, Inc., a pharmaceutical manufacturer based in Pomona, California.
Among these:
- Advanced Relief (dextran 70 0.1% polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 fl oz (15 mL) bottles
- Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 fl oz (15 mL) bottles
- Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%), 0.5 fl oz (15 mL) bottles
- Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), sterile, 0.5 fl oz (15mL) bottles
- Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl oz (15mL) bottles
- Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), 0.5 fl oz (15mL) bottles
- Sterile Eye Drops Redness Lubricant (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) 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
See here for a look at these products on KC’s website.
So where have these products been sold?
Stores and pharmacies across the United States, including CVS, Walgreens, Kroger, H-E-B, Rite Aid, Discount Drug Mart, Gericare, and Best Choice.
Do we know their respective lot numbers and expiration dates?
Expiration dates for each bottle vary, ranging from April 30 to July 31, 2026.
See here for the full list of products, lot numbers, and their expiration dates.
Let’s talk about this “lack of assurance of sterility.”
In product recalls, this means a manufacturer is unable to guarantee a product (such as an eye drop) is free from harmful microorganisms, like bacteria or fungi.
Essentially, it indicates a failure in the manufacturing, testing, or processing of a product that could allow for the potential of contamination—and, as a result, the risk of infection to consumers.
So what led to this specific recall initiation?
Good question. The FDA did not specify what led to the recall, which began on March 3 and was initiated by the manufacturer.
Glance also reached out to KC Pharmaceuticals; the manufacturer did not immediately respond to our request for comment.
And what FDA classification does the recall fall under?
That would be Class II, translating to a situation in which the “use of or exposure to a violative product” could potentially cause:
- Temporary or medically irreversible adverse health consequences
- A remote probability of serious adverse health consequences
In general: Providing a manufacturer has not issued a separate guidance suggesting otherwise, this FDA classification typically does not require consumers to immediately stop the use of an affected product.
Have there been any reports of infections or contamination from these drops?
Not so far … however, if any consumers or eye care providers do have adverse events to report, they should submit a form online via the FDA’s MedWatch Adverse Event Reporting program or by mail/fax.
Noted. It’s been a while since we last had a major eye drop recall …
Indeed it has. Check out our coverage on the voluntary recall of over 75,000 over-the-counter (OTC) eye care products from May 2025.
And who can forget the now-infamous 2023 immediate discontinuation from the Centers for Disease Control and Prevention (CDC) of various OTC artificial tear drops due to an antibiotic-resistant form of bacteria.
- If you remember: This resulted in 81 patient cases across 18 states, 4 deaths, 14 reports of vision loss, and 4 reports of enucleation. See here for our recap.
And see here for another major OTC eye drop warning issued later that year for 27 products.