Lower risk Drug recall · FDA · Published August 26, 2021

Avrio Health Betadine Swabsticks: Subpotent Drug Recall

Avrio Health recalls Betadine Solution Swabsticks with subpotent drug levels. These iodine solutions may not contain enough active ingredient for effective use. Consumers should check product lot numbers and dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0828-2021Drug Avrio Health ›

Lower-risk recall

Subpotent Drug

Take action

Contact the company

Recalling firmAVRIO HEALTH L.P201 Tresser Blvd · Stamford, CT 06901-3435

✎ GovInfoNow plain-language explainer

Avrio Health is recalling Betadine Solution Swabsticks that contain less than the required amount of active ingredient. This means the product may not work as intended for disinfection. If you have these swabsticks, stop using them and contact the manufacturer. Read more at govinfonow.com/recall/35881-avrio-health-betadine-swabsticks-subpotent-drug-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/35881-avrio-health-betadine-swabsticks-subpotent-drug-recall · Updated August 18, 2026 · FDA enforcement record: FDA #D-0828-2021

Cite this page

“Avrio Health Betadine Swabsticks: Subpotent Drug Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35881-avrio-health-betadine-swabsticks-subpotent-drug-recall. Based on FDA recall #D-0828-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0828-2021%22&limit=1).

Avrio Health L.P. voluntarily recalled Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% due to subpotent drug risks, according to the FDA on August 26, 2021.

How to tell if you have it

Brand: Avrio Health
Product: Betadine Solution Swabstick Povidone-Iodine Solution USP, 10%
NDCs: 67618-153-01, 67618-153-03
Lot codes with expiration dates: 11901232 (09/30/2021), 11901549 (11/30/2021), 12000585 (03/31/2022), 12000964 (5/31/2022), 12001457 (7/31/2022), 12002142 (12/31/2022), 12100407 (03/31/2023), 11901231 (09/30/2021), 11901548 (11/30/2021), 12000584 (03/31/2022), 12000963 (05/31/2022), 12001185 (06/30/2022), 12001456 (07/31/2022), 12002150 (12/31/2022), 12100406 (03/31/2023)
Quantity: 75,828 shippers
Distribution: Nationwide

The hazard

The recalled products are classified as subpotent drugs. The FDA announced the Class II recall on August 26, 2021.

Context

GovInfoNow's records show other recent recalls of similar products include Unichem busPIRone 5mg Tablets Recall (2026-04-13), Gasco Isopropyl Alcohol 70% Recall (2026-05-29), and Specialty Process Labs Thyroid Product Recall (2026-01-16).

How to tell if you have this one

Check the product label for the lot number and expiration date. The recalled swabsticks have specific lot numbers and expiration dates listed in the recall notice.

Brand
Avrio Health
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot number and expiration date on the swabstick packaging.
Stop Using Swabsticks
If you have the recalled swabsticks, stop using them immediately.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Product was distributed nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Aug 26, 2021Firm started the recall
Sep 23, 2021FDA classified it Class II
Sep 29, 2021Published in FDA’s Enforcement Report
Apr 12, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/35881-avrio-health-betadine-swabsticks-subpotent-drug-recall">Avrio Health Betadine Swabsticks: Subpotent Drug Recall (GovInfoNow)</a>

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-0828-2021 (August 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0828-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.