Has CareFusion 213, LLC had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 7 total FDA actions tied to CareFusion 213, LLC, including 6 recalls and 1 warning letter.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

Recall Record: Class II Recall: PURPREP by CareFusion 213, LLC

Here's the summary: CareFusion 213, LLC recalled BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41 on 2026-05-13. FDA classified this action as a Class II recall (recall number D-0518-2026). Reason for recall: Lack of assurance of Sterility: potential product contamination. Recall status: Ongoing. This is a drug-category FDA recall record.

Key facts

Recalling firm	CareFusion 213, LLC
Manufacturer	CareFusion 213 LLC
Brand name	PURPREP
Product description	BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41
Classification	Class II
Recall number	D-0518-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Lack of assurance of Sterility: potential product contamination

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is CareFusion 213, LLC and the affected product is described in FDA's record as: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41. FDA's stated reason for the recall is: Lack of assurance of Sterility: potential product contamination. The recall is tracked under FDA recall number D-0518-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41 -- and the recall number D-0518-2026. If it matches, stop using or distributing it and contact CareFusion 213, LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

CareFusion 213, LLC’s FDA history

Argus HQ has recorded 7 total FDA actions tied to CareFusion 213, LLC: 1 warning letter, 6 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has CareFusion 213, LLC had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 7 total FDA actions tied to CareFusion 213, LLC, including 6 recalls and 1 warning letter.
What is the FDA recall number for this event?: FDA recall number D-0518-2026.
What is the current status of this recall?: Status as recorded by FDA: Ongoing.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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Full FDA history for CareFusion 213, LLC

Warning letter: CareFusion 213, LLC — CGMP/Finished Pharmaceuticals/Adulterated (2026-04-30) →

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class II Recall: PURPREP by CareFusion 213, LLC. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-carefusion-213-llc-d-0518-2026

MLA

"Recall Record: Class II Recall: PURPREP by CareFusion 213, LLC." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-carefusion-213-llc-d-0518-2026.

Chicago

Argus HQ Research. "Recall Record: Class II Recall: PURPREP by CareFusion 213, LLC." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-carefusion-213-llc-d-0518-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_carefusion_213_llc_d_0518_2026_2026,
  title = {Recall Record: Class II Recall: PURPREP by CareFusion 213, LLC},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-carefusion-213-llc-d-0518-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗