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.
What this means for you
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
- 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 →Related recalls
Same manufacturer · K.C. Pharmaceuticals, Inc
See all →- HighRugby and Walgreens lubricant eye drops recalled over sterility assurance
FDA (Drugs) · 2026-04-08
- HighGNP redness and dry eye relief drops recalled over sterility assurance
FDA (Drugs) · 2026-04-08
- HighArtificial tears glycerin drops recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-08
- HighLeader artificial tears 15 mL recalled over sterility assurance failure
FDA (Drugs) · 2026-04-08
- HighGoodSense original formula eye drops recalled over sterility assurance
FDA (Drugs) · 2026-04-08
Same hazard · sterility assurance
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereArrow drainage and thoracentesis kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24