Agency classClass IIOur severity:High FDA (Drugs)·D-0412-2026·Announced 2026-04-08

Leader ultra lubricating eye drops recalled over sterility assurance failure

Leader Ultra Lubricating Eye Drops, containing polyethylene glycol 400 and propylene glycol, are being recalled for 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a sterile ophthalmic product whose sterility cannot be assured, with no injuries stated.

Plain-English summary

Leader Ultra Lubricating Eye Drops (polyethylene glycol 400, propylene glycol) are being recalled. About 245,184 bottles were distributed nationwide in the United States. The FDA has classified this recall as Class II.

The recall was initiated for lack of assurance of sterility.

Affected lots are listed in the FDA enforcement record.

Consumers and pharmacies can identify affected product by the lot numbers printed on the pack, and may contact the recalling firm for further information.

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-failure
infection-risk
Affected units: 245,184

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 (18)

Lot: a) SU24E01
SU24E02
Exp.: 5/31/26
SU24K01
Exp.: 9/30/26
b) SU24E01
c) SU24E01
d) SU24E01
e) SU24E01
f) SU24E01
g) SU24E01
SU24E03
h) SU24E01
i) SU24E01
j) SU24E03
k) SU24E02
L) SU24K01
Exp.: 9/30/26.

UPCs (12)

0096295137101
0010939958297
0846036008210
0713733428897
0708820179288
0635515999305
072036735881
311917201672
041415098763
050428396902
050428447383
857005004119

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by K.C. Pharmaceuticals, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same brand · LEADER ULTRA LUBRICATING EYE DROPS

Severe
K.C. Pharmaceuticals Recalls Leader Ultra Lubricating Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14

Same manufacturer · K.C. Pharmaceuticals, Inc

See all →

Severe
K.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Severe
Good Sense Eye Drops Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-10-14
Severe
K.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Severe
K.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Severe
K.C. Pharmaceuticals Recalls Artificial Tears Due to Sterility Concerns
FDA (Drugs) · 2026-10-14

Same hazard · sterility failure