Agency classClass IIOur severity:High FDA (Drugs)·D-0410-2026·Announced 2026-04-08

Quality Choice moisturizing relief eye drops recalled over sterility assurance

Quality Choice Moisturizing Relief Eye Drops, containing dextran 70, polyethylene glycol 400, povidone and tetrahydrozoline hydrochloride, 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

Quality Choice Moisturizing Relief Eye Drops (dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride) are being recalled. About 303,216 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 product covers lot AR24D01 (expiry 04/30/26), lots AR24G01 and AR24G02 (expiry 07/31/26) and lot AR24M01 (expiry 10/31/26), across multiple package configurations listed in the FDA enforcement record.

Consumers and pharmacies can identify affected product by the lot numbers and expiry dates above, and may contact the recalling firm for further information.

The recalled product

Product: QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL)
Brand: QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS
Manufacturer: K.C. Pharmaceuticals, Inc
Category: Drug — Ophthalmic
Hazard: sterility-failure
infection-risk
Affected units: 303,216

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) AR24D01
Exp.: 04/30/26
AR24G01
AR24G02
Exp.: 07/31/26
AR24M01
Exp.: 10/31/26
b) AR24D01
c) AR24D01
d) AR24G02
e) AR24G02
f) AR24G02
g) AR24M01
h) AR24G01
Exp.:10/31/26
I) AR24M01
j) AR24D01
Exp.: 04/30/26.

UPCs (9)

0635515903760
0010939958273
0180410000194
0095072025112
311917200743
050428435441
093351011559
036800036413
095072025563

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 manufacturer · K.C. Pharmaceuticals, Inc

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