CLASS II ONGOING Drug recall · Reported 8 Jul 2026 · FDA Enforcement Report

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalled

CareFusion 213 is recalling BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol, distributed nationwide in the US. The recall was initiated on 11 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: (a) 3214024, 3199359, 3200136, Exp 6/30/2026, 3212372, Exp. 7/31/2026, 3237018, 3243267, 3264290, Exp. 8/31/2026, 3313291, Exp. 10/31/2026, 3334121, Exp. 11/30/2026, 4030693, 4033380, Exp 1/31/2027, 4058103, 4065931, Exp. 2/28/2027, 4093245, 4094302, Exp. 3/31/2027, 4145548, 4146564, Exp. 5/31/2027, 4191049, Exp 6/30/2027, 4214794, 4218807, Exp. 7/31/2027, 4249036, Exp. 8/31/2027, 4254217, 4330005, 4277387, 4275877, 4276225, 4276231, Exp. 9/30/2027, 4304554, 4304577, 4305852, Exp. 10/31/2027, 4332555, Exp. 11/30/2027, 4348701, 4366429, Exp. 12/31/2027, 5016607, 5016609, 5017377, 5018775, Exp. 1/31/2028, 5050801, 5050107, Exp. 2/29/2028, 5076869, 5077722, 5079413, Exp. 3/31/2028, 5112405, 5106576, 5111556, 5118607, 5119243, 5119244, 5127658, Exp. 4/30/2028, 5139589, 5154809, 5157377, Exp. 5/31/2028, 5160633, 5160695, 5177477, Exp.6/30/2028, 5195773, 5195785, 5210771, 5210773, 5210784, 5219294, Exp. 7/31/2028, 5233581, 5247554, 5247987, Exp. 8/31/2028, 5310578, Exp.10/31/2028, 5338383, Exp.11/30/2028, 5343740, 6008264, Exp. 12/31/2028, 6009889, 6031246, 6033968, Exp. 1/31/2029, 6041203, 6059301, 6061876, Exp. 2/28/2029, (b) 3293904, Exp. 10/31/2026, 3333265, Exp. 11/30/2026, 4031672, 1/31/2027, 4061583, 4068589, Exp. 2/28/2027, 4081770, Exp. 3/31/2027, 4154588, 4166005, Exp. 5/31/2027, 4213945, 4215736, Exp. 7/31/2027, 4241055, Exp. 8/31/2027, 4262802, 4270628, Exp. 9/30/2027, 4309640, Exp. 10/31/2027, 5114931, Exp. 4/30/2028, 5135055, 5136752, 5143453, Exp. 5/31/2028, 5165652, Exp. 6/30/2028.

NDC54365-400

Quantity recalled146,600 units

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0645-2026
FDA event ID: 99217
Recalling firm: CareFusion 213, El Paso, TX
Brand: Chloraprep One-step
Manufacturer: CareFusion 213, LLC
Classification: Class II
Status: Ongoing
Recall initiated: 11 Jun 2026
FDA classified: 29 Jun 2026
Reported: 8 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility

Timeline

11 Jun 2026	Recall initiated by company
29 Jun 2026	Classified by FDA	+18 days
8 Jul 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

Where it was distributed

Distributed Nationwide in the USA

Nationwide

Questions about this recall

Is BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol recalled?

Yes. CareFusion 213 recalled BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol on 11 Jun 2026. The recall is Class II and its status is Ongoing. Recall number D-0645-2026.

Why was it recalled?

Which lots are affected?

Lot: (a) 3214024, 3199359, 3200136, Exp 6/30/2026, 3212372, Exp. 7/31/2026, 3237018, 3243267, 3264290, Exp. 8/31/2026, 3313291, Exp. 10/31/2026, 3334121, Exp. 11/30/2026, 4030693, 4033380, Exp 1/31/2027, 4058103, 4065931, Exp. 2/28/2027, 4093245, 4094302, Exp. 3/31/2027, 4145548, 4146564, Exp. 5/31/2027, 4191049, Exp 6/30/2027, 4214794, 4218807, Exp. 7/31/2027, 4249036, Exp. 8/31/2027, 4254217, 4330005, 4277387, 4275877, 4276225, 4276231, Exp. 9/30/2027, 4304554, 4304577, 4305852, Exp. 10/31/2027, 4332555, Exp. 11/30/2027, 4348701, 4366429, Exp. 12/31/2027, 5016607, 5016609, 5017377, 5018775, Exp. 1/31/2028, 5050801, 5050107, Exp. 2/29/2028, 5076869, 5077722, 5079413, Exp. 3/31/2028, 5112405, 5106576, 5111556, 5118607, 5119243, 5119244, 5127658, Exp. 4/30/2028, 5139589, 5154809, 5157377, Exp. 5/31/2028, 5160633, 5160695, 5177477, Exp.6/30/2028, 5195773, 5195785, 5210771, 5210773, 5210784, 5219294, Exp. 7/31/2028, 5233581, 5247554, 5247987, Exp. 8/31/2028, 5310578, Exp.10/31/2028, 5338383, Exp.11/30/2028, 5343740, 6008264, Exp. 12/31/2028, 6009889, 6031246, 6033968, Exp. 1/31/2029, 6041203, 6059301, 6061876, Exp. 2/28/2029, (b) 3293904, Exp. 10/31/2026, 3333265, Exp. 11/30/2026, 4031672, 1/31/2027, 4061583, 4068589, Exp. 2/28/2027, 4081770, Exp. 3/31/2027, 4154588, 4166005, Exp. 5/31/2027, 4213945, 4215736, Exp. 7/31/2027, 4241055, Exp. 8/31/2027, 4262802, 4270628, Exp. 9/30/2027, 4309640, Exp. 10/31/2027, 5114931, Exp. 4/30/2028, 5135055, 5136752, 5143453, Exp. 5/31/2028, 5165652, Exp. 6/30/2028.

Where was it sold?

Distributed Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from CareFusion 213

All 48

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Drug	CLASS II	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD PurPrep, (Povidone-iodine 3% w/w 83% available iodine) recalledPurprep	CareFusion 213	Sterility	Nationwide

Other Chlorhexidine Gluconate recalls

All 37

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine Gluconate	Sage Products	Sterility	Nationwide
22 Jul 2026Drug	CLASS II	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide