Quality & complianceOfficial

FDA lists Class II recall of K.C. Pharmaceuticals tetrahydrozoline eye drops over sterility assurance

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%) is recalled across the US because sterility cannot be assured; the recall is ongoing.

The US Food and Drug Administration has published a Class II drug recall for Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%), a product linked to K.C. Pharmaceuticals, Inc. The entry appears in the agency's enforcement report dated 14 October 2026.

The recall, numbered D-0003-2027, is attributed to a lack of assurance of sterility. The listing gives its status as ongoing and its distribution as US nationwide.

The excerpt available to VigiEye carries no further detail. It does not give lot numbers, quantities, dates of manufacture or distribution, or any information on complaints or adverse events.

As context, FDA applies Class II to recalls where use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the likelihood of serious harm is remote.

What it means for your team

  • Quality teams with ophthalmic or sterile OTC products should note the sterility-assurance reason as a reminder to review aseptic process and sterility testing controls.
  • Distributors and retailers handling this eye drop should check the full FDA enforcement report entry for lot and code details, which were not in the available text.
  • Pharmacovigilance teams may want to watch for any related reports of eye infections or irritation linked to the product, though the source cites none.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

More Quality & compliance All →