K.C. Pharmaceuticals Recall of Sterile Eye Drops Over Sterility

K.C. Pharmaceuticals, Inc. initiated a voluntary recall of Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% (Redness Reliever, Fast Acting Formula) in 0.5 fl oz (15 mL) bottles on September 11, 2026. The FDA assigned recall number D-0007-2027 and classified it Class II on October 5, 2026. The stated reason is lack of assurance of sterility. The recall covers 1,025,448 cartons distributed nationwide in the United States.

At a glance

• The recalling firm is K.C. Pharmaceuticals, Inc. of 3420 Pomona Blvd, Pomona, CA 91768-3236.
• The FDA recorded the action as Voluntary: Firm initiated, with the firm’s initial notification sent by e-mail.
• The FDA classified the recall as Class II, dated October 5, 2026, and listed its status as Ongoing.
• The product is a human OTC ophthalmic drug whose active ingredient is tetrahydrozoline hydrochloride.
• The same recall entry lists 12 store-brand labels, including Best Choice, Good Sense, H.E.B, Harris Teeter, Circle K, Quality Choice, TopCare, Equate, Walgreens and Kroger.

What product did K.C. Pharmaceuticals recall?

The recalled product is Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05%, a redness reliever sold in 0.5 fl oz (15 mL) bottles. The FDA record describes it as a human OTC drug given by the ophthalmic route, meaning a nonprescription product placed in the eye. Tetrahydrozoline hydrochloride is the active ingredient, identified in the openFDA record under substance name TETRAHYDROZOLINE HYDROCHLORIDE.

The recall entry spans multiple store-brand versions made for different distributors. The listed labels are Best Choice (Valu Merchandisers, Co.), Discount drug mart, Good Sense (Geiss, Destin & Dunn, Inc., a Perrigo company), H.E.B Dry Eye, Harris Teeter, Circle K, Lil’ DrugStore, Quality Choice (CDMA Inc), TopCare health (Topco Associates LLC), Equate (Walmart Inc.), Walgreens and Kroger. The FDA record lists package identifiers such as NDC 50804-141-01 for Good Sense, NDC 83324-340-15 for Quality Choice and NDC 79903-158-05 for Equate.

The stated product quantity is 1,025,448 cartons. The distribution pattern is described as US Nationwide.

What does lack of assurance of sterility mean?

A recall reason of lack of assurance of sterility means the firm could not confirm that the product met the sterility expectations applied to it. It is not the same statement as a finding that a specific bottle was contaminated, and the FDA record does not describe any confirmed contamination. The reason field states only “Lack of Assurance of Sterility.”

Sterility matters for eye products because they bypass some of the body’s natural barriers. The recall entry does not describe injuries, infections or test results. It records a firm’s decision to pull product and the agency’s classification of that decision.

What is established vs. what is alleged

Established by the FDA record: K.C. Pharmaceuticals, Inc. initiated a voluntary recall of the named eye drop products on September 11, 2026. The FDA classified the action Class II with a center classification date of October 5, 2026, and reported it on October 14, 2026. The reason given is lack of assurance of sterility. The quantity is 1,025,448 cartons and distribution was nationwide.

Not established by the record: any confirmed contamination of a specific lot, any reported injury, and any finding of wrongdoing. This is a regulatory record of a firm-initiated recall, not a court ruling. No allegation has been tested in court, and the documents supplied here include no filed complaint.

Where the recall stands procedurally

No federal court consolidation exists for this recall. There is no MDL (multidistrict litigation, a procedure that groups related federal cases before one judge) for the K.C. Pharmaceuticals eye drop recall in the documents reviewed here. There is also no Judicial Panel on Multidistrict Litigation (JPML) transfer order, no bellwether trial (a test case chosen from a group to gauge how similar claims may proceed) and no appeal.

The action sits in the FDA’s regulatory process rather than in litigation. The FDA’s Drug Recalls page explains that a recall is a voluntary action taken by a company to remove a defective drug from the market or to warn patients and consumers about a potential risk. That page also states that a terminated recall is one where the FDA has determined that all reasonable efforts have been made to remove or correct the product and proper disposition has been made.

The status in the openFDA entry for D-0007-2027 is Ongoing. The FDA’s recall page does not list this recall among its entries for September and October 2026, and the agency’s page notes that recalls not indicated as terminated are either ongoing or completed.

For comparison, other recall records on the same FDA page carry reasons such as particulate matter and lack of sterility assurance, and readers comparing drug recall patterns can review the American Health Packaging metoclopramide recall overview. Litigation tracks that involve product liability claims about medicines are covered separately, for example in the Depo-Provera meningioma litigation overview.

Key dates

• September 11, 2026: K.C. Pharmaceuticals, Inc. initiated the voluntary recall, per the recall initiation date.
• October 5, 2026: the FDA assigned the Class II classification, per the center classification date.
• October 14, 2026: the FDA reported the recall in its enforcement record, per the report date.
• October 21, 2026: the openFDA drug enforcement dataset carrying this record was last updated.
• October 26, 2026: the FDA’s Drug Recalls page showed content current as of that date, without this recall in its table.

What this does not establish

The record does not show that any illness or injury resulted from these eye drops. It does not identify a contaminating organism, a failed test result or a specific defective lot outside the listed lot and expiration codes. It does not state whether the recall has been completed or terminated, only that its status is Ongoing.

The record also does not establish liability, fault or damages, and it does not create any court case. A Class II classification is a regulatory designation, and the documents reviewed here do not define its criteria beyond the FDA’s general description of the recall process.

Frequently asked questions

What did K.C. Pharmaceuticals recall?

K.C. Pharmaceuticals, Inc. initiated a voluntary recall of Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% in 0.5 fl oz (15 mL) bottles on September 11, 2026. The FDA assigned recall number D-0007-2027 and classified it Class II. The stated reason is lack of assurance of sterility, and the quantity was 1,025,448 cartons distributed nationwide.

Which brands were affected by the K.C. Pharmaceuticals eye drop recall?

The FDA record lists 12 labels, including Best Choice, Discount drug mart, Good Sense, H.E.B Dry Eye, Harris Teeter, Circle K, Lil’ DrugStore, Quality Choice, TopCare health, Equate, Walgreens and Kroger. Each is tied to a distributor named in the recall entry, such as Walmart Inc. for Equate. The record gives lot and expiration codes for each label.

Does the record say these eye drops were contaminated?

No. The FDA record states the reason as lack of assurance of sterility, which describes the firm’s inability to confirm sterility, not a confirmed finding of contamination. The record lists no injuries or failed test results. It documents a firm-initiated recall and the FDA’s Class II classification dated October 5, 2026.

Is there a lawsuit or MDL about this recall?

The documents reviewed here show no lawsuit, MDL or JPML transfer order connected to the K.C. Pharmaceuticals eye drop recall. The action is a regulatory recall recorded by the FDA under number D-0007-2027. No court decision, verdict or settlement appears in the record, and the recall status is listed as Ongoing.

Where can I read the official details of this recall?

The FDA’s openFDA drug enforcement database holds the record for recall number D-0007-2027, including product labels, lot codes and dates. The FDA’s Drug Recalls page describes how the recall process works and explains what a terminated recall means. The openFDA data carries a disclaimer that it should not be relied on for medical decisions and that results are unvalidated.

Sources

1. openFDA (U.S. Food and Drug Administration): “Drug Enforcement Report, Recall Number D-0007-2027” (link, accessed 2026-10-30)
2. U.S. Food and Drug Administration: “Drug Recalls” (link, accessed 2026-10-30)
3. U.S. Food and Drug Administration: “Drug Safety Communications” (link, accessed 2026-10-30)
4. U.S. Food and Drug Administration: “Drugs@FDA Data Files” (link, accessed 2026-10-30)
5. U.S. Food and Drug Administration: “What’s New: Drugs RSS Feed” (link, accessed 2026-10-30)
6. U.S. Food and Drug Administration: “Drug Safety and Availability” (link, accessed 2026-10-30)