Lower risk Drug recall · FDA · Published March 19, 2021
CareFusion ChloraPrep One-Step Solution Recall: Microbial Contamination Risk
CareFusion recalls ChloraPrep One-Step 2% chlorhexidine gluconate and 70% isopropyl alcohol non-sterile solution due to fungal growth at specific storage conditions.
Lower-risk recall
Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Contact the company
Recalling firmCareFusion 213, LLC1550 Northwestern Dr · El Paso, TX 79912-8000
What happened, in plain English
CareFusion is recalling ChloraPrep One-Step 2% chlorhexidine gluconate and 70% isopropyl alcohol non-sterile solution because fungal growth can breach package integrity. This poses a risk of microbial contamination if the product is used without proper sterility. Read more at govinfonow.com/recall/36265-carefusion-chloraprep-one-step-solution-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36265-carefusion-chloraprep-one-step-solution-recall-microbial-contamination-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0345-2021
Cite this page
“CareFusion ChloraPrep One-Step Solution Recall: Microbial Contamination Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36265-carefusion-chloraprep-one-step-solution-recall-microbial-contamination-risk. Based on FDA recall #D-0345-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0345-2021%22&limit=1).
Why it’s dangerous
At temperatures of 30°C and 75% humidity, the product can develop Aspergillus penicillioides fungus, which weakens the packaging. This breach allows contaminants to enter the solution, potentially causing infections if used on open wounds or during medical procedures.
Who’s affected
People who own or use this non-sterile solution for medical purposes, especially those with open wounds or surgical procedures. The risk is low for most users since the product is non-sterile and intended for external use only.
How to tell if you have this one
Look for the product name 'ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution' with the lot numbers listed in the recall notice. The product comes in clear 0.10 fl. oz. (3ml) containers with 25 applicators per carton.
- Brand
CareFusion- Category
Drug
All 8 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Status
Terminated- Distribution
Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.
| Recall number | Product, codes & lots | Quantity | Class | NDC |
|---|---|---|---|---|
| D-0343-2021 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400; Lot and Exp Date: 0065386, 2/28/2023; 0085419, 3/31/2023; 0091666, 3/31/2023; 0149328, 4/30/2023; 0151977, 5/31/2023; 0161217, 5/31/2023; 0175874, 6/30/2023; 0176660, 6/30/2023; 0188805, 6/30/2023; 0211068, 7/31/2023; | 952,100 cartons | Class I | 54365-400-32 |
| D-0344-2021 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415; Lot and Exp Date: 0107872, 4/30/2023; 0108556, 4/30/2023; 0148278, 4/30/2023; 0151978, 5/31/2023; 0155534, 5/31/2023; 0157085, 5/31/2023; 0160618, 5/31/2023; 0167907, 5/31/2023; | 1,434,000 cartons | Class I | 54365-400-33 |
| D-0345-2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400; Lot and Exp Date: 0008777, 12/31/2022; 0016325, 12/31/2022; 0021072, 1/31/2023; 0027041, 1/31/2023; 0030959, 1/31/2023; 0031090, 1/31/2023; 0044735, 1/31/2023; 0048062, 2/28/2023; 0052110, 2/28/2023; 0056365, 2/28/2023; 0086148, 2/28/2023; 0104864, 3/31/2023; 0192894, 6/30/2023; 8081571, 3/31/2021; 8086851, 3/31/2021; 8087784, 3/31/2021; 8095620, 3/31/2021; 8106737, 4/30/2021; 8107819, 4/30/2021; 8124917, 4/30/2021; 8130509, 4/30/2021; 8131816, 4/30/2021; 8135646, 5/31/2021; 8141808, 5/31/2021; 8149992, 5/31/2021; 8155991, 5/31/2021; 8162912, 5/31/2021; 8163900, 5/31/2021; 8165721, 6/30/2021; 8176743, 6/30/2021; 8187644, 6/30/2021; 8194993, 6/30/2021; 8199884, 7/31/2021; 8201565, 7/31/2021; 8205560, 7/31/2021; 8206895, 7/31/2021; 8207995, 7/31/2021; 8221939, 7/31/2021; 8228634, 8/31/2021; 8235981, 8/31/2021; 8247508, 8/31/2021; 8264554, 9/30/2021; 8289654, 9/30/2021; 8299615, 10/31/2021; 8304783, 10/31/2021; 8311788, 10/31/2021; 8316776, 10/31/2021; 8332585, 11/30/2021; 8333924, 11/30/2021; 8337646, 11/30/2021; 8337647, 11/30/2021; 8338794, 11/30/2021; 8340914, 11/30/2021; 8352585, 12/31/2021; 8354835, 12/31/2021; 9007921, 12/31/2021; 9015917, 12/31/2021; 9015920, 12/31/2021; 9030934, 1/31/2022; 9043625, 1/31/2022; 9045819, 1/31/2022; 9046572, 2/28/2022; 9052554, 2/28/2022; 9059817, 2/28/2022; 9060734, 2/28/2022; 9071761, 2/28/2022; 9080812, 3/31/2022; 9087980, 3/31/2022; 9087982, 3/31/2022; 9088850, 3/31/2022; 9092575, 3/31/2022; 9100768, 3/31/2022; 9101529, 3/31/2022; 9105675, 3/31/2022; 9113528, 4/30/2022; 9123753, 4/30/2022; 9130718, 4/30/2022; 9133928, 4/30/2022; 9135816, 5/31/2022; 9149671, 5/31/2022; 9150905, 5/31/2022; 9154935, 5/31/2022; 9156866, 5/31/2022; 9165856, 5/31/2022; 9189224, 6/30/2022; 9194257, 6/30/2022; 9196196, 6/30/2022; 9198900, 6/30/2022; 9199815, 6/30/2022; 9200420, 6/30/2022; 9205441, 7/31/2022; 9206555, 7/31/2022; 9233323, 8/31/2022; 9233645, 8/31/2022; 9236531, 8/31/2022; 9238871, 8/31/2022; 9241929, 8/31/2022; 9242192, 8/31/2022; 9246940, 8/31/2022; 9246944, 8/31/2022; 9249460, 8/31/2022; 9251683, 8/31/2022; 9253785, 8/31/2022; 9254193, 8/31/2022; 9255899, 8/31/2022; 9257889, 8/31/2022; 9261886, 9/30/2022; 9266348, 9/30/2022; 9270894, 9/30/2022; 9278673, 9/30/2022; 9280666, 9/30/2022; 9284872, 9/30/2022; 9289666, 9/30/2022; 9291336, 10/31/2022; 9293445, 10/31/2022; 9295140, 10/31/2022; 9297772, 10/31/2022; 9304891, 10/31/2022; 9305777, 10/31/2022; 9311057, 10/31/2022; 9316346, 11/30/2022; 9325127, 11/30/2022; 9326162, 11/30/2022; 9331792, 11/30/2022; 9344775, 11/30/2022; 9345956, 11/30/2022; 9345958, 11/30/2022; 9350617, 12/31/2022; 9352330, 12/31/2022; | 11,115,774 cartons | Class I | — |
| D-0346-2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415; Lot and Exp Date: 0011737, 1/31/2023; 0020739, 1/31/2023; 0023790, 1/31/2023; 0037278, 1/31/2023; 0037279, 1/31/2023; 0038209, 1/31/2023; 0044734, 12/31/2022; 0007625, 10/31/2022; 0007630, 12/31/2022; 8095632, 3/31/2021; 8116723, 4/30/2021; 8127657, 4/30/2021; 8135651, 5/31/2021; 8137527, 5/31/2021; 8151741, 5/31/2021; 8158638, 5/31/2021; 8164530, 6/30/2021; 8178658, 6/30/2021; 8193779, 6/30/2021; 8197517, 6/30/2021; 8198765, 7/31/2021; 8212881, 7/31/2021; 8220737, 7/31/2021; 8226561, 7/31/2021; 8235991, 8/31/2021; 8249940, 8/31/2021; 8295569, 10/31/2021; 8304501, 10/31/2021; 8304849, 10/31/2021; 8306694, 10/31/2021; 8311791, 10/31/2021; 8334983, 11/30/2021; 8347719, 11/30/2021; 9008965, 12/31/2021; 9011841, 12/31/2021; 9031893, 1/31/2022; 9037824, 1/31/2022; 9038599, 1/31/2022; 9042938, 1/31/2022; 9044573, 1/31/2022; 9045831, 2/28/2022; 9051563, 2/28/2022; 9052565, 2/28/2022; 9053560, 2/28/2022; 9058847, 2/28/2022; 9059821, 2/28/2022; 9067665, 2/28/2022; 9072856, 2/28/2022; 9086532, 3/31/2022; 9087985, 3/31/2022; 9122538, 4/30/2022; 9126562, 4/30/2022; 9126564, 4/30/2022; 9137903, 5/31/2022; 9137904, 5/31/2022; 9154908, 5/31/2022; 9168975, 6/30/2022; 9171618, 6/30/2022; 9191256, 6/30/2022; 9218464, 7/31/2022; 9218595, 7/31/2022; 9221444, 7/31/2022; 9228305, 8/31/2022; 9241932, 8/31/2022; 9247742, 8/31/2022; 9249471, 8/31/2022; 9257903, 8/31/2022; 9263093, 9/30/2022; 9267133, 9/30/2022; 9269603, 9/30/2022; 9282881, 9/30/2022; 9284875, 9/30/2022; 9284881, 9/30/2022; 9289669, 9/30/2022; 9290455, 10/31/2022; 9291279, 10/31/2022; 9295914, 10/31/2022; 9296395, 10/31/2022; 9305775, 11/30/2022; 9311076, 2/28/2023; 9316348, 10/31/2022; 9317310, 11/30/2022; 9317312, 11/30/2022; 9324565, 11/30/2022; 9337530, 11/30/2022; 9341852, 11/30/2022; 9345911, 11/30/2022; 0098528, 12/31/2022; | 6,869,400 cartons | Class I | — |
| D-0347-2021 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400; Lot and Exp Date: 0010759, 11/30/2022; 0025045, 11/30/2022; 0035136, 12/31/2022; 0054691, 2/28/2023; 0057018, 2/28/2023; 0058944, 2/28/2023; 0062656, 2/28/2023; 0063728, 2/28/2023; 0063740, 2/28/2023; 0064594, 2/28/2023; 0065288, 2/28/2023; 0066368, 2/28/2023; 0067288, 3/31/2023; 0069106, 3/31/2023; 0070865, 3/31/2023; 0071359, 3/31/2023; 0072872, 3/31/2023; 0073232, 3/31/2023; 0076029, 3/31/2023; 0077515, 3/31/2023; 0077519, 3/31/2023; 0078347, 3/31/2023; 0079853, 3/31/2023; 0080632, 3/31/2023; 0081061, 3/31/2023; 0081062, 3/31/2023; 0084750, 3/31/2023; 0084754, 3/31/2023; 0084758, 3/31/2023; 0085418, 3/31/2023; 0088774, 3/31/2023; 0090545, 3/31/2023; 0090949, 3/31/2023; 0091664, 3/31/2023; 0092927, 3/31/2023; 0093445, 3/31/2023; 0094039, 3/31/2023; 0005878, 3/31/2023; 0097559, 3/31/2023; 0098525, 3/31/2023; 0099419, 2/28/2023; 0099421, 3/31/2023; 0100379, 3/31/2023; 0105130, 3/31/2023; 0105985, 3/31/2023; 0106926, 4/30/2023; 0106937, 4/30/2023; 0111775, 4/30/2023; 0112982, 4/30/2023; 0113301, 4/30/2023; 0113433, 4/30/2023; 0114091, 4/30/2023; 0114101, 4/30/2023; 0115679, 4/30/2023; 0118820, 4/30/2023; 0119488, 4/30/2023; 0120668, 4/30/2023; 0121257, 4/30/2023; 0121281, 4/30/2023; 0122195, 4/30/2023; 0125774, 4/30/2023; 0126308, 4/30/2023; 0127006, 4/30/2023; 0127856, 4/30/2023; 0128820, 4/30/2023; 0129413, 4/30/2023; 0132806, 4/30/2023; 0132808, 4/30/2023; 0133318, 4/30/2023; 0135284, 4/30/2023; 0136179, 4/30/2023; 0136919, 4/30/2023; 0139776, 4/30/2023; 0139779, 4/30/2023; 0140050, 4/30/2023; 0141253, 4/30/2023; 0142167, 4/30/2023; 0143703, 4/30/2023; 0148151, 4/30/2023; 0149875, 5/31/2023; 0153587, 5/31/2023; 0154180, 5/31/2023; 0154183, 5/31/2023; 0155301, 5/31/2023; 0155611, 5/31/2023; 0156437, 5/31/2023; 0156782, 5/31/2023; 0157078, 5/31/2023; 0160601, 5/31/2023; 0161218, 5/31/2023; 0162594, 5/31/2023; 0162595, 5/31/2023; 0163255, 5/31/2023; 0164591, 6/30/2023; 0167383, 6/30/2023; 0168035, 6/30/2023; 0168225, 6/30/2023; 0169563, 6/30/2023; 0169624, 6/30/2023; 0170815, 6/30/2023; 0171463, 6/30/2023; 0171467, 6/30/2023; 0174318, 6/30/2023; 0174321, 6/30/2023; 0174763, 6/30/2023; 0176737, 6/30/2023; 0177382, 6/30/2023; 0178582, 6/30/2023; 0178584, 6/30/2023; 0188425, 6/30/2023; 0189107, 6/30/2023; 0190185, 6/30/2023; 0192851, 6/30/2023; 0197378, 6/30/2023; 0197837, 6/30/2023; 0198823, 7/31/2023; 0199710, 7/31/2023; 0199720, 6/30/2023; 0199721, 6/30/2023; 0202925, 7/31/2023; 0203832, 6/30/2023; 0204881, 6/30/2023; 0205329, 6/30/2023; 0205331, 6/30/2023; 0206178, 7/31/2023; 0206188, 7/31/2023; 0208782, 7/31/2023; 0209285, 7/31/2023; 0210048, 7/31/2023; 0210638, 7/31/2023; 0211069, 7/31/2023; 0212509, 7/31/2023; 0212627, 7/31/2023; 0213661, 7/31/2023; 0216135, 7/31/2023; 0216992, 7/31/2023; 0216995, 7/31/2023; 0225098, 7/31/2023; 0225257, 7/31/2023; 0226610, 7/31/2023; 0227802, 7/31/2023; 0227838, 7/31/2023; 0228011, 7/31/2023; 0229538, 7/31/2023; 0230050, 7/31/2023; 0230194, 7/31/2023; 0231645, 7/31/2023; 0231646, 7/31/2023; 0232170, 7/31/2023; 0232171, 7/31/2023; 0233607, 7/31/2023; 0233609, 7/31/2023; 0234326, 7/31/2023; 0236941, 8/31/2023; 0237345, 8/31/2023; 0238657, 8/31/2023; 0238658, 8/31/2023; 0239736, 8/31/2023; 0240258, 8/31/2023; 0240259, 8/31/2023; 0241313, 8/31/2023; 0241656, 8/31/2023; 0242880, 8/31/2023; 0244660, 8/31/2023; 0244662, 8/31/2023; 0245775, 7/31/2023; 0246170, 8/31/2023; 0246478, 8/31/2023; 0247206, 8/31/2023; 0248555, 8/31/2023; 0248737, 7/31/2023; 0252884, 8/31/2023; 0253778, 8/31/2023; 0253810, 8/31/2023; 0254567, 8/31/2023; 0254731, 8/31/2023; 0255645, 8/31/2023; 0258252, 8/31/2023; 0258659, 8/31/2023; 0259065, 9/30/2023; 0259898, 9/30/2023; 0260681, 9/30/2023; 0261975, 9/30/2023; 0262729, 9/30/2023; 0265184, 9/30/2023; 0279818, 9/30/2023; 0308327, 10/31/2023; 0309811, 10/31/2023; 0309816, 10/31/2023; 0311453, 10/31/2023; 0312698, 10/31/2023; 0314634, 10/31/2023; 0315662, 10/31/2023; 0316151, 11/30/2023; 0316372, 10/31/2023; 0317672, 11/30/2023; 0318148, 11/30/2023; 0321438, 11/30/2023; 0322315, 11/30/2023; 0323068, 11/30/2023; 0323448, 11/30/2023; 0323503, 11/30/2023; 0324263, 11/30/2023; 0324264, 11/30/2023; 0328929, 11/30/2023; 0329153, 11/30/2023; 0329996, 11/30/2023; 0330665, 11/30/2023; 0335120, 11/30/2023; 0335799, 11/30/2023; 0337020, 11/30/2023; 0338067, 11/30/2023; 0338974, 11/30/2023; 0340677, 11/30/2023; 0343589, 11/30/2023; 0343898, 11/30/2023; 0343903, 11/30/2023; 0344397, 12/31/2023; 0345866, 11/30/2023; 0345870, 11/30/2023; 0346321, 12/31/2023; 0349906, 12/31/2023; 0349907, 12/31/2023; 0350058, 12/31/2023; 0350772, 12/31/2023; 0351193, 12/31/2023; 0351226, 12/31/2023; 0351821, 12/31/2023; 0352445, 11/30/2023; 0352694, 11/30/2023; 0353338, 12/31/2023; 0354300, 12/31/2023; 1008731, 12/31/2023; 1009535, 12/31/2023; 1009538, 12/31/2023; 1012621, 12/31/2023; 1013421, 12/31/2023; 1013423, 12/31/2023; 1014132, 12/31/2023; 1014134, 12/31/2023; 1018037, 12/31/2023; 1018799, 12/31/2023; 1019769, 1/31/2024; 1020849, 1/31/2024; 1021641, 1/31/2024; 1021805, 1/31/2024; 1022415, 1/31/2024; 1022719, 1/31/2024; 1025105, 1/31/2024; 1025854, 1/31/2024; 1025950, 1/31/2024; 1026350, 1/31/2024; 1027907, 1/31/2024; 1028547, 1/31/2024; 1028799, 1/31/2024; 1029694, 1/31/2024; 1030487, 1/31/2024; 1032505, 1/31/2024; 1032717, 1/31/2024; 1033620, 1/31/2024; 1033708, 1/31/2024; 1034917, 1/31/2024; 1035640, 1/31/2024; 1036582, 1/31/2024; 1038982, 1/31/2024; 1039915, 1/31/2024; 1040816, 1/31/2024; 1041348, 1/31/2024; 1041631, 1/31/2024; 1043285, 2/29/2024; 1043350, 1/31/2024; 1048645, 2/29/2024; 1048656, 2/29/2024; 1049461, 2/29/2024; 1049465, 2/29/2024; 1050250, 2/29/2024; 1051583, 2/29/2024; 1051918, 2/29/2024; 1054135, 2/29/2024; 1054728, 2/29/2024; 1055950, 2/29/2024; 1055969, 2/29/2024; 1056752, 2/29/2024; 1057007, 2/29/2024; 1057987, 2/29/2024; 1057988, 2/29/2024; 1059824, 2/29/2024; 1060836, 2/29/2024; 1061724, 2/29/2024; 9305899, 10/31/2022; 9309166, 10/31/2022; 9339182, 11/30/2022; | 24,969,700 cartons | Class II | 54365-400-32 |
| D-0348-2021 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415; Lot and Exp Date: 0018578, 11/30/2022; 0058277, 2/28/2023; 0059141, 2/28/2023; 0066365, 2/28/2023; 0067289, 3/31/2023; 0070866, 3/31/2023; 0074038, 3/31/2023; 0076034, 3/31/2023; 0084619, 3/31/2023; 0086158, 3/31/2023; 0090894, 3/31/2023; 0093903, 3/31/2023; 0095838, 3/31/2023; 0097561, 3/31/2023; 0098470, 3/31/2023; 0100383, 2/28/2023; 0109632, 4/30/2023; 0111185, 4/30/2023; 0113339, 4/30/2023; 0115853, 4/30/2023; 0121982, 4/30/2023; 0122192, 4/30/2023; 0122193, 4/30/2023; 0122194, 4/30/2023; 0128821, 4/30/2023; 0129409, 4/30/2023; 0135287, 4/30/2023; 0157083, 5/31/2023; 0161219, 5/31/2023; 0164032, 6/30/2023; 0164595, 5/31/2023; 0168228, 6/30/2023; 0177338, 6/30/2023; 0177384, 6/30/2023; 0178587, 6/30/2023; 0198836, 7/31/2023; 0199909, 6/30/2023; 0204887, 7/31/2023; 0205674, 6/30/2023; 0206366, 7/31/2023; 0207651, 7/31/2023; 0210578, 7/31/2023; 0227493, 7/31/2023; 0241043, 8/31/2023; 0249695, 8/31/2023; 0252883, 8/31/2023; 0254864, 8/31/2023; 0255091, 8/31/2023; 0259156, 9/30/2023; 0263754, 9/30/2023; 0267575, 9/30/2023; 0272405, 9/30/2023; 0300187, 10/31/2023; 0304315, 10/31/2023; 0305488, 10/31/2023; 0306841, 10/31/2023; 0307140, 9/30/2023; 0312694, 10/31/2023; 0313824, 10/31/2023; 0319649, 11/30/2023; 0324409, 11/30/2023; 0325577, 11/30/2023; 0326746, 11/30/2023; 0330938, 11/30/2023; 0335971, 11/30/2023; 0340937, 11/30/2023; 0347570, 12/31/2023; 0347571, 12/31/2023; 0355671, 12/31/2023; 0356362, 12/31/2023; 1008758, 12/31/2023; 1009747, 12/31/2023; 1028187, 1/31/2024; 1033578, 1/31/2024; 1034948, 1/31/2024; 1035662, 1/31/2024; 1036544, 1/31/2024; 1055547, 2/29/2024; 1060432, 2/29/2024; 9324226, 10/31/2022; 9343836, 11/30/2022; 9344810, 10/31/2022; | 14,275,400 cartons | Class II | 54365-400-33 |
| D-0349-2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400; Lot and Exp Date: 0000192, 12/31/2022; 0007621, 12/31/2022; 0008775, 12/31/2022; 0009111, 12/31/2022; 0011738, 12/31/2022; 0011753, 12/31/2022; 0011754, 12/31/2022; 0011755, 12/31/2022; 0013604, 12/31/2022; 0015498, 12/31/2022; 0015500, 12/31/2022; 0016329, 1/31/2023; 0017929, 12/31/2022; 0021945, 1/31/2023; 0028887, 1/31/2023; 0031093, 1/31/2023; 0034660, 1/31/2023; 0035149, 1/31/2023; 0036460, 1/31/2023; 0037272, 1/31/2023; 0038213, 1/31/2023; 0038217, 1/31/2023; 0041893, 1/31/2023; 0042483, 1/31/2023; 0042501, 1/31/2023; 0043105, 1/31/2023; 0044739, 1/31/2023; 0094838, 2/28/2023; 0098051, 2/28/2023; 0104859, 3/31/2023; 0129330, 4/30/2023; 0133069, 4/30/2023; 0220728, 7/31/2023; 0223036, 7/31/2023; 8078998, 3/31/2021; 8079620, 3/31/2021; 8079621, 3/31/2021; 8082921, 3/31/2021; 8082923, 3/31/2021; 8085804, 3/31/2021; 8088708, 3/31/2021; 8089621, 3/31/2021; 8093619, 3/31/2021; 8093813, 3/31/2021; 8094833, 3/31/2021; 8096706, 3/31/2021; 8097822, 3/31/2021; 8099727, 3/31/2021; 8099783, 3/31/2021; 8100947, 3/31/2021; 8101636, 3/31/2021; 8101719, 3/31/2021; 8102691, 3/31/2021; 8103673, 4/30/2021; 8108795, 4/30/2021; 8109707, 4/30/2021; 8110645, 4/30/2021; 8110674, 4/30/2021; 8114540, 4/30/2021; 8114547, 4/30/2021; 8115574, 4/30/2021; 8116705, 4/30/2021; 8120701, 4/30/2021; 8120985, 4/30/2021; 8122873, 4/30/2021; 8122874, 4/30/2021; 8124914, 4/30/2021; 8127649, 4/30/2021; 8127650, 4/30/2021; 8129680, 4/30/2021; 8129686, 4/30/2021; 8134847, 4/30/2021; 8134850, 4/30/2021; 8136811, 5/31/2021; 8137525, 5/31/2021; 8138867, 5/31/2021; 8141821, 5/31/2021; 8143659, 5/31/2021; 8144768, 5/31/2021; 8144882, 5/31/2021; 8145889, 5/31/2021; 8150625, 5/31/2021; 8151713, 5/31/2021; 8151736, 5/31/2021; 8152581, 5/31/2021; 8156507, 5/31/2021; 8156735, 5/31/2021; 8157866, 5/31/2021; 8157993, 5/31/2021; 8158595, 5/31/2021; 8158633, 5/31/2021; 8159995, 5/31/2021; 8164525, 6/30/2021; 8165696, 6/30/2021; 8167970, 6/30/2021; 8170535, 6/30/2021; 8170538, 6/30/2021; 8171503, 6/30/2021; 8172910, 6/30/2021; 8173655, 6/30/2021; 8176731, 6/30/2021; 8177746, 6/30/2021; 8178576, 6/30/2021; 8178654, 6/30/2021; 8179928, 6/30/2021; 8179974, 6/30/2021; 8180627, 6/30/2021; 8186700, 6/30/2021; 8190916, 6/30/2021; 8190987, 6/30/2021; 8192557, 6/30/2021; 8192881, 6/30/2021; 8197514, 6/30/2021; 8197515, 6/30/2021; 8198763, 7/31/2021; 8199675, 7/31/2021; 8204574, 7/31/2021; 8206898, 7/31/2021; 8211903, 7/31/2021; 8212879, 7/31/2021; 8214989, 7/31/2021; 8214995, 7/31/2021; 8215994, 7/31/2021; 8218645, 7/31/2021; 8219946, 7/31/2021; 8219988, 7/31/2021; 8222798, 7/31/2021; 8225863, 7/31/2021; 8225868, 7/31/2021; 8228632, 8/31/2021; 8229682, 8/31/2021; 8232739, 8/31/2021; 8233569, 8/31/2021; 8235983, 8/31/2021; 8239901, 8/31/2021; 8239902, 8/31/2021; 8240966, 8/31/2021; 8241848, 8/31/2021; 8243756, 8/31/2021; 8247510, 8/31/2021; 8248570, 8/31/2021; 8249934, 8/31/2021; 8257619, 8/31/2021; 8260778, 9/30/2021; 8261945, 9/30/2021; 8261946, 9/30/2021; 8262674, 9/30/2021; 8263865, 9/30/2021; 8265679, 9/30/2021; 8267928, 9/30/2021; 8267929, 9/30/2021; 8268617, 9/30/2021; 8268618, 9/30/2021; 8269913, 9/30/2021; 8271911, 9/30/2021; 8274999, 9/30/2021; 8275615, 9/30/2021; 8275625, 9/30/2021; 8276694, 9/30/2021; 8277635, 9/30/2021; 8277637, 9/30/2021; 8282884, 9/30/2021; 8283738, 9/30/2021; 8284622, 9/30/2021; 8285592, 9/30/2021; 8288852, 9/30/2021; 8290569, 9/30/2021; 8291769, 10/31/2021; 8292703, 10/31/2021; 8292708, 10/31/2021; 8296693, 10/31/2021; 8296695, 10/31/2021; 8299673, 10/31/2021; 8303606, 10/31/2021; 8304839, 10/31/2021; 8306692, 10/31/2021; 8309553, 10/31/2021; 8310641, 10/31/2021; 8311789, 10/31/2021; 8313646, 10/31/2021; 8313687, 10/31/2021; 8319821, 10/31/2021; 8320984, 11/30/2021; 8323514, 11/30/2021; 8323745, 11/30/2021; 8325725, 11/30/2021; 8325749, 11/30/2021; 8331695, 11/30/2021; 8341526, 11/30/2021; 8344689, 11/30/2021; 8345987, 11/30/2021; 8345988, 11/30/2021; 8346840, 11/30/2021; 8347713, 11/30/2021; 8348560, 11/30/2021; 8351524, 12/31/2021; 8351527, 12/31/2021; 8354841, 12/31/2021; 8355555, 12/31/2021; 8355665, 12/31/2021; 9007932, 12/31/2021; 9008954, 12/31/2021; 9008963, 12/31/2021; 9009962, 12/31/2021; 9010973, 12/31/2021; 9014968, 12/31/2021; 9017714, 12/31/2021; 9017716, 12/31/2021; 9021962, 1/31/2022; 9022804, 12/31/2021; 9022808, 12/31/2021; 9023539, 1/31/2022; 9023541, 1/31/2022; 9028693, 1/31/2022; 9030936, 1/31/2022; 9035603, 1/31/2022; 9036759, 1/31/2022; 9036761, 1/31/2022; 9037816, 1/31/2022; 9038527, 1/31/2022; 9039888, 1/31/2022; 9039889, 1/31/2022; 9042932, 1/31/2022; 9043626, 1/31/2022; 9044570, 1/31/2022; 9049788, 2/28/2022; 9049790, 2/28/2022; 9051558, 2/28/2022; 9053553, 2/28/2022; 9053605, 2/28/2022; 9056781, 2/28/2022; 9057597, 2/28/2022; 9057600, 2/28/2022; 9058797, 2/28/2022; 9064561, 2/28/2022; 9067661, 2/28/2022; 9070712, 2/28/2022; 9072853, 2/28/2022; 9073968, 2/28/2022; 9074967, 2/28/2022; 9077861, 2/28/2022; 9079525, 3/31/2022; 9079746, 3/31/2022; 9085737, 3/31/2022; 9093920, 3/31/2022; 9094797, 3/31/2022; 9098940, 3/31/2022; 9099817, 3/31/2022; 9100771, 3/31/2022; 9100776, 3/31/2022; 9106945, 3/31/2022; 9106950, 3/31/2022; 9107765, 4/30/2022; 9107767, 4/30/2022; 9112666, 4/30/2022; 9112668, 4/30/2022; 9113527, 4/30/2022; 9114610, 4/30/2022; 9114611, 4/30/2022; 9116696, 4/30/2022; 9116698, 4/30/2022; 9119832, 4/30/2022; 9120522, 4/30/2022; 9120523, 4/30/2022; 9121774, 4/30/2022; 9122536, 4/30/2022; 9123755, 4/30/2022; 9127963, 4/30/2022; 9127968, 4/30/2022; 9128862, 4/30/2022; 9129660, 4/30/2022; 9130717, 4/30/2022; 9136917, 5/31/2022; 9138989, 5/31/2022; 9140678, 5/31/2022; 9140679, 5/31/2022; 9141792, 5/31/2022; 9143507, 5/31/2022; 9143509, 5/31/2022; 9144771, 5/31/2022; 9144772, 5/31/2022; 9154934, 5/31/2022; 9155527, 5/31/2022; 9155529, 5/31/2022; 9157896, 5/31/2022; 9161567, 5/31/2022; 9162902, 5/31/2022; 9164894, 5/31/2022; 9168973, 6/30/2022; 9171622, 6/30/2022; 9172951, 6/30/2022; 9175686, 6/30/2022; 9179857, 6/30/2022; 9190047, 6/30/2022; 9191255, 6/30/2022; 9192026, 6/30/2022; 9192028, 6/30/2022; 9194258, 6/30/2022; 9196197, 6/30/2022; 9200423, 6/30/2022; 9201209, 7/31/2022; 9204095, 7/31/2022; 9204283, 7/31/2022; 9206983, 7/31/2022; 9207534, 7/31/2022; 9207913, 7/31/2022; 9208099, 7/31/2022; 9211089, 7/31/2022; 9211677, 7/31/2022; 9212097, 7/31/2022; 9213911, 7/31/2022; 9214450, 7/31/2022; 9217995, 7/31/2022; 9218456, 7/31/2022; 9218466, 7/31/2022; 9220319, 7/31/2022; 9220320, 7/31/2022; 9222097, 7/31/2022; 9222098, 7/31/2022; 9222208, 7/31/2022; 9224704, 7/31/2022; 9225074, 7/31/2022; 9225081, 7/31/2022; 9226653, 7/31/2022; 9227526, 7/31/2022; 9227930, 7/31/2022; 9228303, 8/31/2022; 9232762, 8/31/2022; 9234176, 8/31/2022; 9234899, 8/31/2022; 9235837, 8/31/2022; 9236528, 8/31/2022; 9236529, 8/31/2022; 9238869, 8/31/2022; 9239631, 8/31/2022; 9239660, 8/31/2022; 9240736, 8/31/2022; 9241927, 8/31/2022; 9242195, 8/31/2022; 9243015, 8/31/2022; 9247747, 8/31/2022; 9248036, 8/31/2022; 9250289, 8/31/2022; 9250290, 8/31/2022; 9250395, 8/31/2022; 9255902, 8/31/2022; 9256126, 8/31/2022; 9259343, 8/31/2022; 9260247, 8/31/2022; 9260249, 9/30/2022; 9261887, 9/30/2022; 9262353, 9/30/2022; 9263126, 9/30/2022; 9264104, 9/30/2022; 9264107, 9/30/2022; 9266082, 9/30/2022; 9266337, 9/30/2022; 9267130, 9/30/2022; 9267132, 9/30/2022; 9268809, 9/30/2022; 9269989, 9/30/2022; 9269991, 9/30/2022; 9270898, 9/30/2022; 9271954, 9/30/2022; 9275594, 9/30/2022; 9276137, 9/30/2022; 9276159, 9/30/2022; 9278674, 9/30/2022; 9281274, 9/30/2022; 9282883, 9/30/2022; 9283393, 9/30/2022; 9287360, 9/30/2022; 9288429, 9/30/2022; 9289665, 9/30/2022; 9290448, 9/30/2022; 9293444, 10/31/2022; 9295579, 9/30/2022; 9296389, 10/31/2022; 9296399, 10/31/2022; 9297775, 10/31/2022; 9298637, 10/31/2022; 9298640, 10/31/2022; 9301749, 10/31/2022; 9301762, 10/31/2022; 9302581, 10/31/2022; 9302586, 10/31/2022; 9303414, 10/31/2022; 9303758, 10/31/2022; 9305773, 10/31/2022; 9309480, 10/31/2022; 9309567, 10/31/2022; 9311065, 10/31/2022; 9313838, 10/31/2022; 9313839, 10/31/2022; 9316341, 10/31/2022; 9317266, 11/30/2022; 9318804, 11/30/2022; 9318806, 11/30/2022; 9319143, 11/30/2022; 9320067, 11/30/2022; 9323280, 11/30/2022; 9323406, 11/30/2022; 9324538, 11/30/2022; 9324707, 11/30/2022; 9325125, 11/30/2022; 9327963, 11/30/2022; 9329366, 11/30/2022; 9329368, 11/30/2022; 9330598, 11/30/2022; 9331805, 11/30/2022; 9338115, 11/30/2022; 9338129, 11/30/2022; 9340890, 11/30/2022; 9343956, 11/30/2022; 9343958, 11/30/2022; 9344779, 11/30/2022; 9347277, 10/31/2022; 9351555, 12/31/2022; 9353728, 12/31/2022; 9354163, 12/31/2022; 9354165, 12/31/2022; | 40,720,900 cartons | Class II | — |
| D-0350-2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415; Lots and Exp dates: 0009104, 12/31/2022; 0013602, 12/31/2022; 0016431, 1/31/2023; 0022273, 1/31/2023; 0023788, 1/31/2023; 0029135, 1/31/2023; 0032694, 1/31/2023; 0038211, 1/31/2023; 0044741, 1/31/2023; 0064598, 2/28/2023; 0104862, 3/31/2023; 0127010, 4/30/2023; 0196060, 6/30/2023; 0224915, 7/31/2023; 8024958, 1/9/2021; 8025595, 1/31/2021; 8025597, 1/31/2021; 8031857, 1/31/2021; 8033645, 1/31/2021; 8038971, 1/28/2021; 8043969, 1/22/2021; 8043978, 1/31/2021; 8046513, 2/1/2021; 8046721, 1/29/2021; 8053669, 2/28/2021; 8053699, 2/28/2021; 8053947, 2/28/2021; 8055949, 2/28/2021; 8059513, 2/28/2021; 8059562, 2/28/2021; 8061970, 2/19/2021; 8064854, 2/28/2021; 8066666, 2/28/2021; 8068686, 2/28/2021; 8069986, 2/28/2021; 8073868, 2/28/2021; 8087798, 3/31/2021; 8099735, 3/31/2021; 8101641, 3/31/2021; 8106743, 4/30/2021; 8107945, 4/30/2021; 8120678, 4/30/2021; 8122947, 4/30/2021; 8131539, 4/30/2021; 8145833, 5/31/2021; 8155989, 5/31/2021; 8172690, 6/30/2021; 8173860, 6/30/2021; 8191600, 6/30/2021; 8221942, 7/31/2021; 8234936, 8/31/2021; 8243851, 8/31/2021; 8247688, 8/31/2021; 8250928, 8/31/2021; 8253987, 8/31/2021; 8256638, 8/31/2021; 8260782, 8/31/2021; 8265685, 9/30/2021; 8274504, 9/30/2021; 8276704, 9/30/2021; 8282698, 9/30/2021; 8284625, 9/30/2021; 8288853, 9/30/2021; 8338776, 11/30/2021; 8339985, 11/30/2021; 8351538, 12/31/2021; 8355672, 12/31/2021; 9007942, 12/31/2021; 9014571, 12/31/2021; 9017726, 1/31/2022; 9021969, 12/31/2021; 9024576, 1/31/2022; 9030949, 1/31/2022; 9078586, 3/31/2022; 9087987, 3/31/2022; 9092771, 3/31/2022; 9128867, 4/30/2022; 9129671, 4/30/2022; 9135822, 5/31/2022; 9143840, 5/31/2022; 9154907, 5/31/2022; 9154939, 5/31/2022; 9158658, 5/31/2022; 9164579, 5/31/2022; 9175663, 6/30/2022; 9176284, 6/30/2022; 9197931, 6/30/2022; 9199822, 6/30/2022; 9200426, 7/31/2022; 9205380, 7/31/2022; 9207927, 7/31/2022; 9213913, 7/31/2022; 9221459, 7/31/2022; 9224855, 7/31/2022; 9231815, 8/31/2022; 9232764, 8/31/2022; 9233646, 8/31/2022; 9235839, 8/31/2022; 9248040, 8/31/2022; 9261980, 9/30/2022; 9270896, 9/30/2022; 9301763, 10/31/2022; 9310176, 10/31/2022; 9317270, 11/30/2022; 9327966, 11/30/2022; 9327969, 11/30/2022; 9339209, 11/30/2022; 9344806, 11/30/2022; 9345964, 10/31/2022; 9351402, 12/31/2022; | 7,990,100 cartons | Class II | — |
What to do — step by step
Check Product Details
Identify the product by checking the lot number and expiration date on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How can I tell if my product is affected?
Look for the lot numbers listed in the recall notice: 0008777 through 9352330 with expiration dates up to December 31, 2022.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0345-2021 (March 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0345-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.