The Recall Desk
HighFDA (Drugs)·D-0441-2025·Announced 2025-05-28

[pending] CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)

Pending LLM rewrite. Source: FDA_DRUG D-0441-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

The recalled product

Product
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Brand
CHLORAPREP ONE-STEP
Manufacturer
CareFusion 213, LLC

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 (2)

  • Lot #s: 3354127 and 3350974
  • Exp Date: 12/31/2026

Distribution

Distributed nationwide across the United States.

Same brand · CHLORAPREP ONE-STEP