Agency classClass IIOur severity:Severe FDA (Drugs)·D-0004-2027·Announced 2026-10-14

K.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns

K.C. Pharmaceuticals is recalling Leader Advanced Relief Eye Drops and related brands due to a lack of assurance of sterility. The recall covers 208,896 cartons distributed nationwide.

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 source identifies the hazard as a lack of assurance of sterility in eye drops, which is an FDA Class II recall. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

K.C. Pharmaceuticals, Inc. is recalling 208,896 cartons of Leader Advanced Relief Eye Drops and several other private-label eye drop products. The recall is being conducted because of a lack of assurance of sterility in the affected products. The products are sterile eye drops containing dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline HCl, packaged in 0.5 FL OZ (15 mL) bottles.

The affected products are sold under multiple brand names, including Leader, Equaline, GoodSense, H.E.B A.C. Eye Drops, Medic'c Choice, Foster & Thrive, Colirio Manzanill A+, P, QC-Quality Choice, and TopCare health. The recall covers specific lots with expiration dates ranging from January 1, 2027, to November 30, 2027. The products were distributed nationwide in the United States.

Consumers should stop using the recalled eye drops and return them to the place of purchase for a refund. The FDA has classified 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 ADVANCED RELIEF EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL)
Brand: LEADER ADVANCED RELIEF EYE DROPS
Manufacturer: K.C. Pharmaceuticals, Inc.
Category: Drug — Ophthalmic
Hazard: sterility
Affected units: 208,896

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 (15)

Lot: a) AR25A02
Exp.: 1/1/2027
b) AR25A02
c) AR25A01
AR25N01
Exp.: 11/30/2027
d) AR25A02
e) AR25A02
f) AR25A02
g) AR25F01
Exp.: 6/30/2027
h) AR25A02
I) AR25A01
J) AR25A01
Exp.: 1/1/2027.

UPCs (10)

0096295136470
0180410000194
0095072012518
0010939958273
0635515903760
041163253926
041220437450
184125000180
041415067769
036800036413

Distribution

Distributed nationwide across the United States.

Same manufacturer · K.C. Pharmaceuticals, Inc.

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