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Use caution Drug recall · FDA · Published March 4, 2013

CareFusion Recalls SEPP Povidone Iodine Solution Due to Sterility Claims

CareFusion recalls SEPP 10% Povidone Iodine Solution because labeling misleadingly claims sterility for a non-sterile product.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-226-2013DrugCareFusion ›
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Contact the company

Recalling firmCareFusion 213, LLC1550 Northwestern Drive · El Paso, TX 79912-8000
✎ GovInfoNow plain-language explainer

CareFusion 213, LLC is recalling SEPP 10% Povidone Iodine Solution because the product is not sterile, but the labeling implies it is. This misbranding affects applicators distributed nationwide and internationally between 2011 and 2015. The recall addresses a Class II violation where consumers might incorrectly assume the solution is safe for sterile procedures. Read more at govinfonow.com/recall/48307-carefusion-213-llc-recalls-sepp-10-povidone-iodine-solution-usp.

Source Summary by GovInfoNow · govinfonow.com/recall/48307-carefusion-213-llc-recalls-sepp-10-povidone-iodine-solution-usp · Updated October 13, 2026 · FDA enforcement record: FDA #D-226-2013

Cite this page

“CareFusion Recalls SEPP Povidone Iodine Solution Due to Sterility Claims.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48307-carefusion-213-llc-recalls-sepp-10-povidone-iodine-solution-usp. Based on FDA recall #D-226-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-226-2013%22&limit=1).

The FDA announced on March 4, 2013, that CareFusion 213, LLC is recalling SEPP Povidone Iodine Solution because the product is not sterile and its labeling misleadingly claims sterility. The agency issued recall number D-226-2013 for the Class II voluntary recall.

How to tell if you have it

  • Brand: CareFusion
  • Product: SEPP Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water)
  • Packaging: 200-count applicators (Net 0.67 mL each) per carton; 3000-count applicators per case
  • Catalog Numbers: Cat. No 260286; Cat. No 260681
  • NDC: 54365-145-01
  • Manufacturer Location: CareFusion, Leawood, KS 66211
  • Lot Expiry Dates (Cartons): Between 09/12 and 10/15
  • Lot Expiry Dates (Cases): Between 10/11 and 07/14
  • Units Affected: 8,960,000 applicators

The hazard

The product is misbranded because it is not sterile while the labeling makes sterility claims. The FDA classified this as a Class II recall due to the misleading nature of the packaging regarding sterility.

Context

GovInfoNow's records show CareFusion 213, LLC has 16 other recalls on record since 2011-11-08. Other recent recalls involving similar sterility risks include BD ChloraPrep Clear 60x1mL (2026-07-09), CareFusion ChloraPrep Clear 100x10.5mL (2026-06-11), and CareFusion BD ChloraPrep Clear 1mL Applicator (2026-05-28). Other recent recalls of similar products include Carolina Infusion Quad-Mix Injectable (2026-09-10), New Life Pharma Semaglutide Injections (2026-02-26), and Huons Co. Bupivacaine Ampules (2026-04-02).

How to tell if you have this one

Check if you have SEPP 10% Povidone Iodine Solution USP packaged in 200-count or 3000-count applicators. Look for Cat. No 260286 (NDC 54365-145-01) or Cat. No 260681. Verify the lot expiration date is between 09/12 to 10/15 or 10/11 to 07/14.

  • Brand
    CareFusion
  • Category
    Drug
FDA recall event · 6 products

All 6 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.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
Recall numberProduct, codes & lotsQuantity
D-224-2013SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS 66211.; All lots distributed between 01/10 to 02/13698,000 applicators
D-225-2013SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, NDC 54365-161-01, CareFusion, Leawood, KS 66211; b) 3000-count applicators (Net 0.67 mL each) per case, Cat. No 260431, NDC 54365-151-01, CareFusion, Leawood, KS 66211; and c) 3000-count applicators (Net 0.67 mL each) per case, Reorder TA6200, Manufactured for: Tri-State Hospital Supply Corporation, Howell, MI 48843.; a) All lots with expiry between 02/12 to 10/15; b) All lots with expiry between 09/11 to 12/13; and c) All lots with expiry between 12/11 to 12/11.3,032,000 applicators
D-226-2013SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, CareFusion, Leawood, KS 66211, Cat. No 260286, NDC 54365-145-01; and b) 3000-count applicators per case, Cat. No 260681, CareFusion, Leawood, KS 66211.; a) All lots with expiry between 09/12 to 10/15 and b) All lots with expiry between 10/11 to 07/14.8,960,000 applicators
D-227-2013Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260307, NDC 54365-200-99, CareFusion, Leawood, KS 66211.; All lots with expiry between 12/11 to 10/15.929,000 kits
D-228-2013Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, CareFusion, Leawood, KS 66211.; All lots with expiry between 09/11 to 09/13.46,500 kits
D-229-2013FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, CareFusion, Leawood, KS 66211.; All lots with expiry between 07/11 to 08/14.544,500 kits
Based on the official FDA remedy

What to do — step by step

  1. Check your product details

    Verify if you have the recalled SEPP Povidone Iodine Solution by checking the category number and expiration date against the recall list.

  2. Discontinue use for sterile purposes

    Do not use this product for any procedure requiring sterility, as it is not sterile despite labeling claims.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom” 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 14 months after the firm started it.

1. Firm started the recall: Mar 4, 201312. FDA classified it Class II: Mar 28, 201323. Published in FDA’s Enforcement Report: Apr 3, 201334. FDA terminated the recall: May 12, 2014420132014
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Which specific lots are affected by this recall?

All lots with expiry dates between 09/12 to 10/15 (for 200-count applicators) and all lots with expiry dates between 10/11 to 07/14 (for 3000-count applicators).

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Other CareFusion recalls

CareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL
July 9, 2026CareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60
May 28, 2026CareFusion 213, LLC recalls BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL
December 17, 2025CareFusion 213, LLC recalls BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient
February 14, 2025

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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-226-2013 (March 4, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-226-2013 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA