August 2026 FDA Recall Chlorhexidine Gluconate by Sage Products, Llc
D-0837-2026 - Cross Contamination with Other Products
This Class II drug recall was voluntarily initiated by Sage Products, Llc on August 18, 2026 for the product Chlorhexidine Gluconate. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0837-2026
Cross Contamination with Other Products
08-18-2026
09-09-2026
165,536 packages
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sage Products, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26
Batch or Lot Expiration Information
Lot# Lot 108491 with case sequence numbers 14841 through 20013.
