Medications & Supplements/Topical Products

Betadine Solution Swabsticks Recalled for Being Subpotent

Agency Publication Date: September 23, 2021

Summary

Avrio Health L.P. is recalling Betadine Solution Swabstick Antiseptic (povidone-iodine solution, 10%) because the medication is subpotent, meaning it contains less of the active ingredient than required. Approximately 75,828 shippers are affected by this recall, which includes both single and three-count non-sterile swabsticks used for skin preparation. No incidents or injuries related to this issue have been reported to date.

Risk

Because the product is subpotent, it may not effectively reduce bacteria on the skin as intended. This failure to properly disinfect can increase the risk of infection when the swabsticks are used for skin preparation before medical procedures.

What You Should Do

This recall affects Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% in single and three-count packs under NDC numbers 67618-153-01 and 67618-153-03.
Check the lot number and expiration date printed on your swabstick packaging. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Avrio Health L.P. directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Betadine Solution Swabstick Povidone-Iodine Solution USP, 10%

Variants: Single count, Three count, Non-Sterile Solution

Lot Numbers:

11901232 (Exp. Date 09/30/2021)

11901549 (Exp. Date 11/30/2021)

12000585 (Exp. Date 03/31/2022)

12000964 (Exp. Date 05/31/2022)

12001457 (Exp. Date 07/31/2022)

12002142 (Exp. Date 12/31/2022)

12100407 (Exp. Date 03/31/2023)

11901231 (Exp. Date 09/30/2021)

11901548 (Exp. Date 11/30/2021)

12000584 (Exp. Date 03/31/2022)

12000963 (Exp. Date 05/31/2022)

12001185 (Exp. Date 06/30/2022)

12001456 (Exp. Date 07/31/2022)

12002150 (Exp. Date 12/31/2022)

12100406 (Exp. Date 03/31/2023)

NDC:

67618-153-01

67618-153-03

Avrio Health LP Stamford, CT 06901-3431

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88539

Status: Resolved

Manufacturer: AVRIO HEALTH L.P

Sold By: pharmacies; hospitals; medical supply distributors

Manufactured In: United States

Units Affected: 75,828 shippers

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% in single and three-count packs under NDC numbers 67618-153-01 and 67618-153-03.

Check the lot number and expiration date printed on your swabstick packaging. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Avrio Health L.P. directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Betadine Solution Swabstick Povidone-Iodine Solution USP, 10%

Variants: Single count, Three count, Non-Sterile Solution

Lot Numbers:

11901232 (Exp. Date 09/30/2021)

11901549 (Exp. Date 11/30/2021)

12000585 (Exp. Date 03/31/2022)

12000964 (Exp. Date 05/31/2022)

12001457 (Exp. Date 07/31/2022)

12002142 (Exp. Date 12/31/2022)

12100407 (Exp. Date 03/31/2023)

11901231 (Exp. Date 09/30/2021)

11901548 (Exp. Date 11/30/2021)

12000584 (Exp. Date 03/31/2022)

12000963 (Exp. Date 05/31/2022)

12001185 (Exp. Date 06/30/2022)

12001456 (Exp. Date 07/31/2022)

12002150 (Exp. Date 12/31/2022)

12100406 (Exp. Date 03/31/2023)

NDC:

67618-153-01

67618-153-03

Avrio Health LP Stamford, CT 06901-3431