Recalls / Active ingredient / Chlorhexidine Gluconate

Chlorhexidine Gluconate

19 FDA drug recalls involving the active ingredient “Chlorhexidine Gluconate” — 7 Class I.

Date	Class	Product	Firm
2025-12-17	Class II	BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v),	CareFusion 213, LLC
2025-05-15	Class II	BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoper	CareFusion 213, LLC
2025-02-14	Class I	BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA),	CareFusion 213, LLC
2023-08-25	Class II	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution	CareFusion 213, LLC
2022-02-04	Class II	Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as	Professional Disposables International, Inc.
2022-02-04	Class II	Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) On	Professional Disposables International, Inc.
2022-02-04	Class II	Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swa	Professional Disposables International, Inc.
2021-05-14	Class III	READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Si	Medline Industries Inc
2021-04-20	Class I	BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alco	CareFusion 213, LLC
2021-03-19	Class II	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution	CareFusion 213, LLC
2021-03-19	Class I	BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile	CareFusion 213, LLC
2021-03-19	Class I	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution	CareFusion 213, LLC
2021-03-19	Class II	BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile	CareFusion 213, LLC
2020-07-07	Class I	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution	CareFusion 213, LLC
2020-07-07	Class I	BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile	CareFusion 213, LLC
2020-06-23	Class I	BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)	CareFusion 213, LLC
2017-06-01	Class II	Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories	Xttrium Laboratories Inc
2016-07-29	Class II	2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case	Sage Products LLC
2016-02-12	Class III	Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottle	Ecolab Inc