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Over-the-counter medicine · no prescription needed

Chlorhexidine and isopropyl alcohol

Purpose on the label: Antiseptic Antiseptic

Antiseptics and hand sanitizers

Official FDA data, not advice

The label text is quoted exactly as the company filed it with the U.S. Food and Drug Administration (FDA), with a link to the official copy. The list of brands comes from the FDA NDC Directory.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

If someone may have taken too much, call Poison Help: 1‑800‑222‑1222. In an emergency, call 911.

Quick answers

What is Chlorhexidine and isopropyl alcohol used for?
The Drug Facts label of 3M SoluPrep S (Solventum US LLC) lists these uses: patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection Uses patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection Uses patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection.
Do I need a prescription for Chlorhexidine and isopropyl alcohol?
No. The products on this page are sold without a prescription (over the counter).
Is a store brand the same as the name brand?
Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
Has Chlorhexidine and isopropyl alcohol been recalled?
FDA enforcement reports list 30 recalls of products on this page; the newest started July 9, 2026. A recall usually concerns specific products or lots, not every brand.

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

3M SoluPrep S · Solventum US LLC

Chlorhexidine gluconate 20 mg/mL · Isopropyl alcohol 70%, solution (topical)

Active ingredient

Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v

Purpose

Antiseptic Antiseptic Purpose Antiseptic Antiseptic Purpose Antiseptic Antiseptic

Uses

patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection Uses patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection Uses patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection

Warnings

For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: do not use 26-mL applicator for head and neck surgery do not use on an area smaller than 8.4 in. x 15.6 in. Use a smaller applicator instead. solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow solution to pool remove wet materials from prep area Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

on patients with known allergies to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser

When using this product

keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. to avoid skin injury, care should be taken when removing drapes, tapes, etc.

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. Warnings For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow solution to pool remove wet materials from prep area Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

on patients with known allergies to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser

When using this product

keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. to avoid skin injury, care should be taken when removing drapes, tapes, etc.

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. Warnings For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow solution to pool remove wet materials from prep area Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

on patients with known allergies to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser

When using this product

keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. to avoid skin injury, care should be taken when removing drapes, tapes, etc.

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

(follow all directions for use) use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. discard the applicator after a single use along with any portion of the solution not required to cover the prepped area. It is not necessary to use the entire amount available. Getting Patient Ready for Solution: use in well-ventilated area do not microwave or heat the solution applicator apply to clean, completely dry, residue-free, intact skin when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues. Activating the Applicator: remove applicator from package; do not touch sponge with sponge face parallel to the floor, press the cap end of the applicator. Solution will begin to flow into sponge. When Applying Solution: completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes maximal treatment area for one applicator is approximately 13.2 in. x 21.6 in. (285.2 in 2 ). do not allow solution to pool ; tuck prep towels to absorb solution, and then remove clean umbilicus with enclosed swabs when applicable. (Moisten swabs by pressing against solution-soaked sponge applicator.) avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry. After Applying Solution: to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) While Waiting for Solution to Completely Dry: do not drape or use ignition source (e.g., cautery, laser) check for pooled solution. Use sterile gauze to soak up pooled solution. Do not blot because it may remove solution from skin. remove wet materials from prep area. Replace if necessary. After Solution is Completely Dry: to reduce the risk of fire, begin draping and/or using cautery only after solution is completely dry and all wet materials are removed if incise drapes are used, apply directly to dry prep apply dressing following standard practices Directions (follow all directions for use) use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. discard the applicator after a single use along with any portion of the solution not required to cover the prepped area. It is not necessary to use the entire amount available. Getting Patient Ready for Solution: use in well-ventilated area do not microwave or heat the solution applicator apply to clean, completely dry, residue-free, intact skin when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues. Activating the Applicator: remove applicator from package; do not touch sponge grasp products by wrapping hand and fingers around the labeled portion of the applicator. Place thumb on the lever with sponge face parallel to the floor, snap lever to allow fluid to flow into sponge. When Applying Solution: completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes maximal treatment area for one applicator is approximately 8.4 in. x 15.6 in. (131.4 in 2 ). do not allow solution to pool ; tuck prep towels to absorb solution, and then remove avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry. After Applying Solution: to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) While Waiting for Solution to Completely Dry: do not drape or use ignition source (e.g., cautery, laser) check for pooled solution. Use sterile gauze to soak up pooled solution. Do not blot because it may remove solution from skin. remove wet materials from prep area. Replace if necessary. After Solution is Completely Dry: to reduce the risk of fire, begin draping and/or using cautery only after solution is completely dry and all wet materials are removed if incise drapes are used, apply directly to dry prep apply dressing following standard practices Directions (follow all directions for use) use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. discard the applicator after a single use along with any portion of the solution not required to cover the prepped area. It is not necessary to use the entire amount available. Getting Patient Ready for Solution: use in well-ventilated area do not microwave or heat the solution applicator apply to clean, completely dry, residue-free, intact skin when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues. Activating the Applicator: remove applicator from package; do not touch sponge grasp product by wrapping hand and fingers around the labeled portion of the applicator. Place thumb on the lever with sponge face parallel to the floor, snap lever to allow fluid to flow into sponge. When Applying Solution: completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes maximal treatment area for one applicator is approximately 8.4 in. x 15.6 in. (131.4 in 2 ) do not allow solution to pool ; tuck prep towels to absorb solution, and then remove avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry. After Applying Solution: to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) While Waiting for Solution to Completely Dry: do not drape or use ignition source (e.g., cautery, laser) check for pooled solution. Use sterile gauze to soak up pooled solution. Do not blot because it may remove solution from skin. remove wet materials from prep area. Replace if necessary. After Solution is Completely Dry: to reduce the risk of fire, begin draping and/or using cautery only after solution is completely dry and all wet materials are removed if incise drapes are used, apply directly to dry prep apply dressing following standard practices

Other information

store between 15-30 °C (59-86 °F) avoid freezing and excessive heat above 40 °C (104 °F) The tint will slowly fade from the skin. For early removal of surgical prep use soap and water or 70% Isopropyl Alcohol. Other information store between 15-30 °C (59-86 °F) avoid freezing and excessive heat above 40 °C (104 °F) The tint will slowly fade from the skin. For early removal of surgical prep use soap and water or 70% Isopropyl Alcohol. Other information store between 15-30 °C (59-86 °F) avoid freezing and excessive heat above 40 °C (104 °F)

Inactive ingredients

acetyltri-n-butyl citrate, FD&C blue #1, FD&C yellow #5, purified water USP, Trisodium HEDTA Inactive ingredients acetyltri-n-butyl citrate, FD&C blue #1, FD&C yellow #5, purified water USP, Trisodium HEDTA Inactive ingredients acetyltri-n-butyl citrate, purified water USP, Trisodium HEDTA

Questions?

call 1-800-228-3957 (Monday-Friday 7AM-6PM CST). www.3M.com/Medical 34-8727-1905-8 Questions? call 1-800-228-3957 (Monday-Friday 7AM-6PM CST). www.3M.com/Medical 34-8727-1906-6 Questions? call 1-800-228-3957 (Monday-Friday 7AM-6PM CST). www.3M.com/Medical 34-8727-1907-4

— FDA label of 3M SoluPrep S, Solventum US LLC, effective April 23, 2026. See the official label on DailyMed →

Prevantics Swabstick · Professional Disposables International, Inc.

Chlorhexidine gluconate 31.5 mg/mL · Isopropyl alcohol 70%, solution (topical)

Active ingredient

Chlorhexidine gluconate 3.15% w/v Isopropyl alcohol 70% v/v

Purpose

Antiseptic Antiseptic

Uses

for the preparation of the patient's skin prior to surgery or injection

Warnings

For external use only Flammable, keep away from fire or flame

Do not use

with electrocautery procedures Allergy alert This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

on patients allergic to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser under occlusive patch

When using this product

keep out of eyes, ears, mouth and mucous membranes. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. maximum treatment area for one maxi swabstick is approximately: dry site: 4 by 4 inches (10 by 10 cm) or moist site: 3 by 5 inches (7.5 by 12.5 cm) tear open the pouch to expose the swabstick remove the swabstick from package. Do not touch the foam tip. prior to surgery or injection, apply one flat side of foam tip to the proposed skin site and prep the skin in vigorous back-and-forth repeated strokes, turning the swabstick over (unused side of the foam tip) half way in the procedure dry site: scrub repeatedly back and forth for 15 seconds with each side of the applicator for a total of 30 seconds. Allow to air dry for approximately 30 seconds. moist site: scrub repeatedly back and forth for 1 minute with each side of the applicator for a total of 2 minutes. Allow to air dry for approximately 1.5 minutes. do not blot or wipe dry discard after a single use

Inactive ingredients

USP purified water

— FDA label of Prevantics Swabstick, Professional Disposables International, Inc., effective February 10, 2025. See the official label on DailyMed →

Swab Stick 2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyI alcohol (IPA) · Xinxiang Xinda Technology Co., Ltd

Chlorhexidine gluconate 20 mg/mL · Isopropyl alcohol 70%, swab (topical)

Active ingredient

Chlorhexidine gluconate 2% w/w Isopropyl alcohol 70% v/v

Purpose

Antiseptic

Uses

Usage For skin antisepsis prior to an invasive procedure. Helps reduce bacteria content that could cause skin infections.

Warnings

For external and professional use only. Avoid contact with eyes, interior of ears and mucous membranes. Single-use product.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Dosage Apply to areas that need to be disinfected

Inactive ingredients

Water

— FDA label of Swab Stick 2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyI alcohol (IPA), Xinxiang Xinda Technology Co., Ltd, effective May 24, 2026. See the official label on DailyMed →

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

Chlorhexidine gluconate 20 mg/mL · Isopropyl alcohol 70% · solution (topical) · 5 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
3M SoluPrep S Solventum US LLC DailyMed
Chloraprep HF Acquisition Co LLC, DBA HealthFirst DailyMed
ChloraPrep One-Step CareFusion 213, LLC —
ChloraPrep Swabstick CareFusion 213 LLC DailyMed
Chlorhexidine gluconate 31.5 mg/mL · Isopropyl alcohol 70% · solution (topical) · 3 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Prevantics Maxi Swabstick Professional Disposables International, Inc. DailyMed
Prevantics Swab Professional Disposables International, Inc. DailyMed
Prevantics Swabstick Professional Disposables International, Inc. DailyMed
Chlorhexidine gluconate 20 mg/mL · Isopropyl alcohol 70% · swab (topical) · 2 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Swab Applicator Brushes 2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyI alcohol (IPA) Xinxiang Xinda Technology Co., Ltd DailyMed
Swab Stick 2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyI alcohol (IPA) Xinxiang Xinda Technology Co., Ltd DailyMed

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific products or lots: check the name and lot number on your package.

  1. July 9, 2026 · Class II · Ongoing · D-0690-2026

    Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

    BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, D — CareFusion 213, LLC

  2. June 11, 2026 · Class II · Ongoing · D-0643-2026

    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

    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applic — CareFusion 213, LLC

  3. June 11, 2026 · Class II · Ongoing · D-0645-2026

    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

    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 — CareFusion 213, LLC

  4. June 11, 2026 · Class II · Ongoing · D-0646-2026

    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

    ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC — CareFusion 213, LLC

  5. June 11, 2026 · Class II · Ongoing · D-0647-2026

    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

    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catal — CareFusion 213, LLC

  6. June 11, 2026 · Class II · Ongoing · D-0648-2026

    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

    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, b — CareFusion 213, LLC

  7. June 11, 2026 · Class II · Ongoing · D-0651-2026

    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

    BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365- — CareFusion 213, LLC

  8. June 11, 2026 · Class II · Ongoing · D-0650-2026

    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

    BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54 — CareFusion 213, LLC

  9. June 11, 2026 · Class II · Ongoing · D-0649-2026

    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

    BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, — CareFusion 213, LLC

  10. June 11, 2026 · Class II · Ongoing · D-0652-2026

    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

    BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 543 — CareFusion 213, LLC

  11. May 28, 2026 · Class II · Ongoing · D-0623-2026

    Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

    BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Di — CareFusion 213, LLC

  12. May 28, 2026 · Class I · Ongoing · D-0624-2026

    Non-Sterility: Due to presence of Aspergillus penicillioides.

    BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of B — CareFusion 213, LLC

  13. May 28, 2026 · Class I · Ongoing · D-0625-2026

    Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

    BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Di — CareFusion 213, LLC

  14. May 28, 2026 · Class II · Ongoing · D-0622-2026

    Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

    BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson — CareFusion 213, LLC

  15. December 17, 2025 · Class II · Ongoing · D-0243-2026

    Lack of Assurance of Sterlity

    BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29 — CareFusion 213, LLC

Showing the newest 15 of 30.

Next steps

Sources

  1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

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