Agency classClass IIOur severity:Severe FDA (Drugs)·D-0002-2027·Announced 2026-10-14

K.C. Pharmaceuticals Recalls Artificial Tears Due to Sterility Concerns

K.C. Pharmaceuticals is recalling 505,896 cartons of artificial tears sold under multiple brands because the product lacks assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II due to a lack of assurance of sterility in an ophthalmic product. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

K.C. Pharmaceuticals, Inc. is recalling 505,896 cartons of artificial tears (polyvinyl alcohol 0.5%, povidone 0.6%) in 15 mL bottles. The recall is due to a lack of assurance of sterility. The affected product is distributed nationwide under various brand names, including Leader, Good Neighbor Pharmacy, Good Sense, Medic'c Choice, Quality Choice, TopCare Health, Walgreens, and Kroger.

The recall covers specific lot numbers with expiration dates ranging from November 30, 2026, to September 30, 2027. Consumers should check their bottles for the lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and return it to the place of purchase for a refund or contact the manufacturer for further instructions.

The recalled product

Product: LEADER ARTIFICIAL TEARS 15 ML (POLYVINYL ALCOHOL, POVIDONE)
Brand: LEADER ARTIFICIAL TEARS 15 ML
Manufacturer: K.C. Pharmaceuticals, Inc.
Category: Drug — Ophthalmic
Hazard: sterility
Affected units: 505,896

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot: a) AT25B01
Exp.: 2/28/2027
b) AT24N01
Exp.: 11/30/2026
AT25B01
AT25D01
Exp.: 04/30/27
AT25F01
Exp.: 6/30/2027
AT25F02
AT25K02
Exp.: 9/30/2027
c) AT25D01
d) AT24N01
AT25K01
e) AT25B01
f) AT25B01
g) AT25B01
h) AT25B01
I) AT25D01

UPCs (10)

0096295137644
0087701104060
0180410000163
0095072015519
0635515992238
070038470083
041415009769
036800093317
311917065038
011110386007

Distribution

Distributed nationwide across the United States.

Same brand · LEADER ARTIFICIAL TEARS 15 ML

High
Leader artificial tears 15 mL recalled over sterility assurance failure
FDA (Drugs) · 2026-04-08

Same manufacturer · K.C. Pharmaceuticals, Inc.

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Good Sense Eye Drops Recalled for Lack of Sterility Assurance
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K.C. Pharmaceuticals Recalls Leader Ultra Lubricating Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Severe
K.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14

Same hazard · sterility