Purdue Betadine Swabsticks May Have Subpotent Drug Due to Packaging Issue
Purdue Pharma recalls Betadine Swabsticks with potential subpotent iodine due to packaging defect. Affected lots expire 12/31/18 to 08/31/2019. Consumers should check product details and contact Purdue for guidance.
Lower-risk recall
Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
Contact the company
What happened, in plain English
Purdue Pharma is recalling Betadine Swabsticks that may have reduced drug strength because of a packaging defect. This could mean the solution isn't as effective for disinfection as it should be. Read more at govinfonow.com/recall/41158-purdue-betadine-swabsticks-may-have-subpotent-drug-due-to-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/41158-purdue-betadine-swabsticks-may-have-subpotent-drug-due-to-packaging · Updated October 7, 2026 · FDA enforcement record: FDA #D-0070-2018
Cite this page
“Purdue Betadine Swabsticks May Have Subpotent Drug Due to Packaging Issue.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41158-purdue-betadine-swabsticks-may-have-subpotent-drug-due-to-packaging. Based on FDA recall #D-0070-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0070-2018%22&limit=1).
Why it’s dangerous
The pouches were made with the aluminum layer touching the product, causing a chemical reaction that reduced the iodine concentration. This makes the solution less effective for disinfection.
Who’s affected
People who own or use Betadine Swabsticks with the specific lot numbers listed in the recall (expiring 12/31/18 to 08/31/2019) are affected. Those using the product for medical purposes may be at slightly higher risk if the solution is less effective.
How to tell if you have this one
Check the product label for the lot numbers: 62823 (expiring 12/31/18), 64304 (expiring 05/31/2019), 64711 (expiring 08/31/2019), or 65915 (expiring 12/31/2019). The product is labeled as Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.
- Brand
Purdue- Category
Drug
What to do — step by step
Check Product Details
Look for the lot numbers 62823, 64304, 64711, or 65915 on the label to determine if your swabstick is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 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-0070-2018 (October 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0070-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.