Agency classClass IIOur severity:High FDA (Drugs)·D-0409-2026·Announced 2026-04-08

Quality Choice irritation relief eye drops recalled over sterility assurance

Quality Choice Eye Drops Irritation Relief, containing tetrahydrozoline HCl and zinc sulfate, are being recalled for lack of assurance of sterility. 182,424 bottles are affected.

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: FDA Class II recall of a sterile ophthalmic product where sterility cannot be assured, a risk of harm with no illnesses reported in the source.

Plain-English summary

Quality Choice Eye Drops Irritation Relief, an over-the-counter ophthalmic solution containing tetrahydrozoline hydrochloride and zinc sulfate, is being recalled. The action covers 182,424 bottles.

The stated reason is lack of assurance of sterility. Ophthalmic products are required to be sterile because the eye has limited defences against introduced organisms. The FDA classified the action as Class II.

The product was distributed nationwide in the United States and is sold over the counter to consumers.

Consumers who have the recalled eye drops should stop using them and contact the pharmacy or retailer where they were purchased. Anyone who has used the product and has concerns about their eyes should speak to a healthcare professional.

The recalled product

Product: QUALITY CHOICE EYE DROPS IRRITATION RELIEF (TETRAHYDROZOLINE HCL, ZINC SULFATE)
Brand: QUALITY CHOICE EYE DROPS IRRITATION RELIEF
Manufacturer: K.C. Pharmaceuticals, Inc
Category: Drug — Ophthalmic solution
Hazard: sterility-assurance
ophthalmic
otc-drug
class-ii
Affected units: 182,424

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 (11)

Lot: a) AC24E01
Exp.: 05/31/26
b) AC24E01
c) AC24E01
d) AC24E01
e) AC24E01
f) AC24E01
g) AC24E01
h)AC24E01
i) AC24E01
j) AC24E01

UPCs (9)

0635515995055
0846036008210
0041250829188
070038470106
093351011580
311917179544
041163251144
036800036406
041220437467

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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Same hazard · sterility assurance