Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 54365-0014-41 recalled?

PurPrep · 1 APPLICATOR in 1 POUCH (54365-014-41) / 10.5 mL in 1 APPLICATOR

Yes — this exact package was recalled

1 FDA recall names the code 54365-0014-41 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

3 of these recalls are still ongoing.

Active ingredient
povidone iodine and isopropyl alcohol
Strength
ISOPROPYL ALCOHOL 725 mg/mL; POVIDONE-IODINE 8.3 mg/mL
Form
Sponge · Topical
Labeler
CareFusion 213 LLC
Type
Human OTC Drug
Product code
54365-0014

Recalls naming this package

Class II · Moderate risk

BD PurPrep

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

Ongoing Sterility / contamination CareFusion 213, LLC NDC 54365-014-42 D-0644-2026
Class II · Moderate risk

BD PurPrep

Lack of assurance of Sterility: potential product contamination

Ongoing Sterility / contamination CareFusion 213, LLC NDC 54365-014-41 D-0518-2026
Class II · Moderate risk

BD PurPrep

Lack of assurance of Sterility: potential product contamination

Ongoing Sterility / contamination CareFusion 213, LLC NDC 54365-014-42 D-0517-2026

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler