Degasa Povidone Iodine Recall: Label Mix-Up Hazard
Degasa recalls 1-gallon bottles of Povidone Iodine USP Prep Solution due to a labeling error where 7.5% product was labeled as 10%. Check your lot number.
Use caution until it’s fixed
Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Contact the company
What happened, in plain English
Degasa Sa De Cv is recalling Povidone Iodine, USP Prep Solution because the finished product contained 7.5% concentration but was incorrectly labeled as 10%. This labeling mix-up occurred in bottles packaged in 1-gallon containers sold in California and Illinois. The outer boxes had the correct label, but the bottle itself was mislabeled. Read more at govinfonow.com/recall/41409-degasa-povidone-iodine-recall-label-mix-up-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/41409-degasa-povidone-iodine-recall-label-mix-up-hazard · Updated October 11, 2026 · FDA enforcement record: FDA #D-1129-2017
Cite this page
“Degasa Povidone Iodine Recall: Label Mix-Up Hazard.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41409-degasa-povidone-iodine-recall-label-mix-up-hazard. Based on FDA recall #D-1129-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1129-2017%22&limit=1).
Why it’s dangerous
Using a lower concentration of antiseptic than intended (7.5% instead of 10%) may result in inadequate skin preparation before medical procedures, potentially increasing the risk of infection. The discrepancy creates confusion about the actual potency of the solution being used.
Who’s affected
Healthcare providers and consumers who purchased Povidone Iodine Prep Solution from California or Illinois between the manufacturing date and recall date are likely affected. Users relying on the specific 10% concentration for medical prep may receive a different strength.
How to tell if you have this one
Check if you have a 1-gallon bottle of Povidone Iodine, USP Prep Solution, OTC, manufactured for PSS World Medical, Inc. Look for NDC 68345-350-09 and Lot # 3A176011 with an expiration date of 10/18. The product was made in Mexico.
- Brand
Degasa- Category
Drug
What to do — step by step
Check your inventory
Verify if you have bottles matching NDC 68345-350-09, Lot # 3A176011, Exp 10/18.
Contact the manufacturer
Since no remedy is stated in the record, contact Degasa Sa De Cv or PSS World Medical for further instructions on how to handle the mislabeled product.
Where it went and when
Where it was distributed
Distributed in California and Illinois.
FDA distribution: “CA, IL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois.
Recall timeline
FDA terminated this recall 3.3 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-1129-2017 (August 4, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1129-2017 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.