Agency classClass IIOur severity:Severe FDA (Drugs)·D-0006-2027·Announced 2026-10-14

K.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns

K.C. Pharmaceuticals is recalling 1,327,248 cartons of dry eye relief eye drops due to a lack of assurance of sterility. The products were 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 eye drops, a hazard that may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

K.C. Pharmaceuticals, Inc. is recalling 1,327,248 cartons of LEADER DRY EYE RELIEF EYE DROPS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400). The recall is being conducted because of a lack of assurance of sterility in the product. The affected products are sterile lubricant dry eye relief eye drops, 0.5 FL OZ (15 mL).

The recalled products were distributed nationwide in the United States. They are sold under various brand names and distributors, including LEADER (distributed by Cardinal Health), Crocodile Tears, Discount Drug Mart, Exchange Select, GERI CARE, H.E.B Dry Eye, Harris Teeter, Foster & Thrive, and TopCare health. Specific lot numbers and expiration dates are listed in the recall documentation, ranging from February 2027 to November 2027.

Consumers who have purchased these products should stop using them and return them to the place of purchase for a refund or contact the manufacturer for further instructions. The FDA classifies this recall as Class II, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product: LEADER DRY EYE RELIEF EYE DROPS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400)
Brand: LEADER DRY EYE RELIEF EYE DROPS
Manufacturer: K.C. Pharmaceuticals, Inc.
Category: Drug — Ophthalmic
Hazard: lack-of-sterility
Affected units: 1,327,248

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) LT25B01
Exp.: 02/28/2027
b) LT25D02
Exp.: 04/30/2027
LT25K01
Exp.: 09/30/2027
c) LT25D02
d) LT25D02
LT25M02
Exp.: 10/31/2027
e) LT25B01
LT25D01
LT25D02
LT25M01
LT25N01
Exp.: 11/30/2027
LT25N02
f) LT25B01
g) LT25M02
h) LT25B01

UPCs (10)

0096295137064
0096295137071
0357896184056
0010939958266
867166000004
093351011566
614299056206
041220437412
072036713032
036800361003

Distribution

Distributed nationwide across the United States.

Same manufacturer · K.C. Pharmaceuticals, Inc.

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Same hazard · lack of sterility