FDA-Drug2026-09-09Class IIPROCESSING DEFECT

Sage Products 2% Chlorhexidine Gluconate Cloth recalled for cross-contamination risk

OTHERNationwide distributionDrugs

What this means

Sage Products is recalling specific lots of 2% Chlorhexidine Gluconate non-sterile cloths due to potential cross-contamination with other products during manufacturing. The affected cloths may not meet safety and quality standards. No injuries have been reported.

  • Check if you have Lot 108491 with case sequence numbers 14841–20013 (printed on packaging).
  • Stop using affected cloths and contact Sage Products or your supplier for instructions on return or disposal.
  • If you use these cloths in a medical or healthcare setting, notify your infection control team.
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The agency's original wording
Hazard

Cross Contamination with Other Products

Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
165,536 packages
Manufactured in
3909 3 Oaks Rd, N/A, Cary, IL, United States
Products
2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0837-2026

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