Agency classClass IIOur severity:Severe FDA (Drugs)·D-0009-2027·Announced 2026-10-14

K.C. Pharmaceuticals Recalls Leader Ultra Lubricating Eye Drops for Sterility Concerns

K.C. Pharmaceuticals is recalling 163,008 cartons of Leader Ultra Lubricating Eye Drops due to a lack of assurance of sterility. The product was distributed nationwide under multiple brand names.

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 163,008 cartons of Leader Ultra Lubricating Eye Drops (Polyethylene Glycol 400, Propylene Glycol). The recall was initiated because of a lack of assurance of sterility in the product. The affected eye drops are sterile high-performance lubricating drops intended to relieve dry and irritated eyes.

The recalled product was distributed nationwide in the United States. It is available under several brand names and distribution channels, including Leader (distributed by Cardinal Health), exchange select (manufactured for military exchanges), Good Sense (distributed by Perrigo Direct Inc.), and Walgreens. Specific lot numbers and expiration dates are listed in the recall details, including lots SU25B01 and SU25N01 with expiration dates in 2027.

Consumers who have purchased these eye drops should stop using them immediately. They should check their lot numbers and expiration dates against the recall information provided by the FDA or the manufacturer. If the product matches the recalled lots, consumers should return it to the place of purchase for a refund or contact the manufacturer for further instructions.

The recalled product

Product: LEADER ULTRA LUBRICATING EYE DROPS (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL)
Brand: LEADER ULTRA LUBRICATING EYE DROPS
Manufacturer: K.C. Pharmaceuticals, Inc.
Category: Drug — Ophthalmic
Hazard: sterility
Affected units: 163,008

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 (9)

Lot: a) SU25B01
Exp.: 02/28/2027
b) SU25N01
Exp.: 11/30/2027
c) SU25B01
SU25N01
SU25N02
d) SU25B01
Exp.: 02/28/2027.

UPCs (4)

0096295137101
0846036008210
614299056190
311917201672

Distribution

Distributed nationwide across the United States.

Same brand · LEADER ULTRA LUBRICATING EYE DROPS

High
Leader ultra lubricating eye drops recalled over sterility assurance failure
FDA (Drugs) · 2026-04-08

Same manufacturer · K.C. Pharmaceuticals, Inc.

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Same hazard · sterility