Overview
A drug recall is a voluntary or FDA-requested action taken by a manufacturer to remove a medication from the market, or to correct it, because it does not meet safety, quality, or labeling standards. Recalls are one of the primary tools the FDA and drug manufacturers use to protect patients once a problem is discovered after a product has already reached pharmacies and consumers.
This specific drug recall involving PURPREP, POVIDONE IODINE AND ISOPROPYL ALCOHOL is classified as Class II, and was reported on May 13, 2026 by CareFusion 213, LLC.
The sections below explain, in plain language, what is known about this drug recall, who it may affect, and what steps patients and caregivers can reasonably take. This article is an independent summary written for educational purposes and is not a substitute for the official FDA notice linked at the end of this page.
What Happened
CareFusion 213, LLC initiated action on PURPREP, POVIDONE IODINE AND ISOPROPYL ALCOHOL on May 13, 2026 after identifying possible contamination or a sterility concern. The action affects specific lots or units of this medication rather than every unit ever produced, so not every package on the market is necessarily involved.
The action is described in FDA records as voluntary: firm initiated, and its current status in FDA records is listed as "Ongoing". Recall status can change as the firm works through correction or removal, so the most current information is always the official FDA recall record linked below.
Affected Products
The product identified in this notice is PURPREP, POVIDONE IODINE AND ISOPROPYL ALCOHOL, manufactured or distributed by CareFusion 213, LLC.
FDA records describe the affected product 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
Identifying details on record include specific lot numbers, batch codes, or serial numbers documented as Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.; distribution reported as Nationwide in the USA; origin or reporting location of El Paso, TX, United States. If you have this product, compare it against these identifiers before assuming it is affected — many recalls apply to only a subset of lots, not an entire product line.
Reason
Based on FDA records, this notice was driven by possible contamination or a sterility concern. In general terms, this kind of issue is flagged because it has the potential to affect how safely or effectively the product performs once it reaches a patient.
According to the FDA's Drug Enforcement Report database, the stated reason was: "Lack of assurance of Sterility: potential product contamination"