Medline Recalls PVP Scrub Solution Due to Subpotent Drug Risk
Medline recalls 67,104 bottles of PVP Scrub Solution because the iodine content may be lower than labeled. Check your lot number.
Use caution until it’s fixed
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Contact the company
What happened, in plain English
Medline Industries Inc is recalling PVP Scrub Solution (Povidone Iodine) because it may not meet the required iodine assay levels through its labeled expiry date. This means the antiseptic might be less effective than expected when used for skin preparation. The recall affects approximately 67,104 bottles distributed nationwide in the USA and Curacao. Read more at govinfonow.com/recall/40808-medline-recalls-pvp-scrub-solution-due-to-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40808-medline-recalls-pvp-scrub-solution-due-to-subpotent-drug-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0546-2018
Cite this page
“Medline Recalls PVP Scrub Solution Due to Subpotent Drug Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40808-medline-recalls-pvp-scrub-solution-due-to-subpotent-drug-risk. Based on FDA recall #D-0546-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0546-2018%22&limit=1).
Why it’s dangerous
The product is classified as a subpotent drug, meaning it does not meet the labeled iodine assay requirements through its expiry date. Using a subpotent antiseptic may result in inadequate skin preparation, potentially increasing the risk of infection if used for medical or surgical procedures.
Who’s affected
Consumers who purchased PVP Scrub Solution from retailers across the USA and Curacao between unspecified dates prior to February 2018. Individuals relying on this specific lot for skin antisepsis are most at risk of receiving a subpotent product.
How to tell if you have this one
Check your bottle for Product Number MDS093945 and NDC 53329-938-04. Verify the Lot number is 16EJ0023 with an expiration date of 04/18. The bottle contains 4 FL OZ of solution and was manufactured in the USA by Medline Industries, Inc.
- Brand
Medline- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your PVP Scrub Solution matches Product Number MDS093945, NDC 53329-938-04, Lot 16EJ0023, Exp 04/18.
Contact Medline
The record does not specify a return or replacement process; contact Medline Industries Inc for further instructions.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Curacao” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0546-2018 (February 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0546-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.