CHLORHEXIDINE GLUCONATE
Recalling Firm / Manufacturer: Sage Products, LLC
(Cary, IL, United States)
FDA Recall Number: D-0837-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
CHLORHEXIDINE GLUCONATE
Generic Name
CHLORHEXIDINE GLUCONATE
Active Substance(s)
Chlorhexidine Gluconate
Administration Route
Topical
National Drug Code (NDC)
53462-705
Total Quantity Recalled
165,536 packages
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Cross Contamination with Other Products
Full Product Description
Packaging specifications and labeling details
2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
September 09, 2026
Firm Initiation Date
August 18, 2026
FDA Classification Date
Sep 11, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot 108491 with case sequence numbers 14841 through 20013.
Distribution Information
Geographic scope of affected shipments
US Nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0837-2026
Questo Retrieval Date: September 23, 2026 00:00 1790121612UTCC