Chlorhexidine Gluconate Cloth (Sage) – Potential Contamination (2016)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.
Brand
Sage Products LLC
Lot Codes / Batch Numbers
Lot #: a) 50749, Exp. 9/29/16, 50765, Exp. 9/30/16, 50771, Exp. 9/30/16, 50773, Exp. 10/01/16, 52839, Exp. 2/9/17, 52843, Exp. 2/9/17, 52855, Exp. 2/10/17, 52861, Exp. 2/10/17, 53840, Exp. 4/21/17, 56081, Exp. 9/1/17, 56513, Exp. 9/26/17, b) 54760, Exp. 6/15/17, c) 54763, Exp. 6/16/17 a) Lot # 50749, Exp. 9/29/2016, Lot # 50765, Exp. 9/30/2016, Lot # 50771, Exp. 9/30/2016, Lot # 50773, Exp. 10/1/2016, Lot # 52839, Exp. 2/9/2017, Lot # 52843, Exp. 2/9/2017, Lot # 52855, Exp. 2/10/2017, Lot # 52861, Exp. 2/10/2017, Lot # 53840, Exp. 4/21/2017 . b) Lot # 54763, Exp. 6/16/2017. c) Lot # 54760, Exp. 6/15/2017.
Products Sold
Lot #: a) 50749, Exp. 9/29/16; 50765, Exp. 9/30/16; 50771, Exp. 9/30/16; 50773, Exp. 10/01/16; 52839, Exp. 2/9/17; 52843, Exp. 2/9/17; 52855, Exp. 2/10/17; 52861, Exp. 2/10/17; 53840, Exp. 4/21/17; 56081, Exp. 9/1/17; 56513, Exp. 9/26/17; b) 54760, Exp. 6/15/17; c) 54763, Exp. 6/16/17 a) Lot # 50749 , Exp. 9/29/2016 ; Lot # 50765 , Exp. 9/30/2016 ; Lot # 50771 , Exp. 9/30/2016 ; Lot # 50773 , Exp. 10/1/2016 ; Lot # 52839 , Exp. 2/9/2017 ; Lot # 52843 , Exp. 2/9/2017 ; Lot # 52855 , Exp. 2/10/2017 ; Lot # 52861 , Exp. 2/10/2017 ; Lot # 53840 , Exp. 4/21/2017 . b) Lot # 54763, Exp. 6/16/2017. c) Lot # 54760, Exp. 6/15/2017.
Sage Products LLC is recalling 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 package due to CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026