Agency classClass IIOur severity:High FDA (Drugs)·D-0413-2026·Announced 2026-04-08

GoodSense original formula eye drops recalled over sterility assurance

GoodSense Eye Drops Original Formula, containing 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

GoodSense Eye Drops Original Formula (tetrahydrozoline hydrochloride) are being recalled. About 378,144 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 RG24E01 (expiry 05/31/26) and lots RG24G01 and RG24G02 (expiry 07/31/26), 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: GOODSENSE EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
Brand: GOODSENSE EYE DROPS ORIGINAL FORMULA
Manufacturer: K.C. Pharmaceuticals, Inc
Category: Drug — Ophthalmic
Hazard: sterility-failure
infection-risk
Affected units: 378,144

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) RG24E01
Exp.: 05/31/26
RG24G02
Exp.: 07/31/26
b) RG24E01
c) RG24G02
d) RG24E01
RG24G01
e) RG24E01
f) RG24E01
g) RG24E01
h) RG24E01
i) RG24E01
j) RG24E01
k) RG24E01
L) RG24E01
m) RG24E01
n) RG24G01
o) RG24G01
p) RG24G02

UPCs (11)

0180410000156
311917200736
311917200767
366715683243
072036713025
041220437474
041163251106
194283651858
095072005565
036800036390
070038470113

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 · GOODSENSE EYE DROPS ORIGINAL FORMULA

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

Same manufacturer · K.C. Pharmaceuticals, Inc

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Good Sense Eye Drops Recalled for Lack of Sterility Assurance
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Same hazard · sterility failure