FDAClass IIRecall started September 11, 2026

Sterile EYE Drops AC 0.05% Recall: Sterility Concern

Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; b) Good Sense Sterile Eye Drops, Distributed By: Geiss, Destin & Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-121-01; c) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7; d) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; e) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6.

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was Sterile EYE Drops AC 0.05% recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Which lot codes, UPCs or models are affected?

Lot: a) AC25C01, Exp.: 3/31/2027; b) AC25B01, Exp.: 2/28/2027; AC25C01, Exp.: 3/31/2027; c) AC25C01, Exp.: 3/31/2027; d) AC25C01, Exp.: 3/31/2027; e) AC25C01, Exp.: 3/31/2027.

Agency record number
D-0003-2027
Product
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; b) Good Sense Sterile Eye Drops, Distributed By: Geiss, Destin & Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-121-01; c) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7; d) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; e) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6.
Recalling firm
K.C. Pharmaceuticals, Inc.
Quantity
182,016 cartons
Distribution
US Nationwide
Recall started
September 11, 2026
Report date
October 14, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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