Agency classClass IIOur severity:Severe FDA (Drugs)·D-0008-2027·Announced 2026-10-14

K.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns

K.C. Pharmaceuticals is recalling multiple brands of eye drops, including Leader, Equate, and Walgreens, due to a lack of 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, which indicates a reasonable probability of serious adverse health consequences or death, specifically due to a lack of assurance of sterility. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

K.C. Pharmaceuticals, Inc. is recalling multiple brands of sterile eye drops, including Leader, Discount Drug Mart, Equaline, Colirio Ojo de Aguila, Clear Eyes, Equate, Walgreens, and Xpect Industrial Eye Relief. The products contain Glycerin 0.25% and Naphazoline Hydrochloride 0.02% and are distributed nationwide in the United States.

The recall is being conducted because of a lack of assurance of sterility. The source text does not report any illnesses, injuries, or deaths associated with the use of these products.

Consumers should stop using the recalled eye drops and check their lot numbers and expiration dates against the list provided by the manufacturer. Affected lots include various codes such as RL25D01, RL25G01, and RL25K05, with expiration dates ranging from April 2027 to August 2028.

The recalled product

Product: LEADER EYE DROPS REDNESS RELIEF (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE)
Brand: LEADER EYE DROPS REDNESS RELIEF
Manufacturer: K.C. Pharmaceuticals, Inc.
Category: Drug — Ophthalmic
Hazard: lack-of-sterility

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) RL25D01
Exp.: 04/30/2027
RL25G01
Exp.: 07/31/2027
RL25K05
Exp.: 09/30/2027
RL25N03
Exp.: 11/30/2027
b) RL25D01
c) RL25D01
d) RL25E01
Exp.: 05/31/2027
e) RL25G02
RL25G03
RL25G04
RL25H02
Exp.: 08/30/2028
RL25H03
RL25H04
RL25K01

UPCs (8)

0096295137620
0096295137637
0681131395342
093351034114
041163461512
348201016155
678112254156
311917177410

Distribution

Distributed nationwide across the United States.

Same brand · LEADER EYE DROPS REDNESS RELIEF

High
GNP redness and dry eye relief drops recalled over sterility assurance
FDA (Drugs) · 2026-04-08

Same manufacturer · K.C. Pharmaceuticals, Inc.

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Same hazard · lack of sterility