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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Purdue Pharma, LP: Betadine Swabsticks Recalled Due to Packaging Defect and Reduced Potency

Agency Publication Date: November 3, 2017
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Summary

Purdue Pharma, LP is recalling approximately 3,997 units of Betadine Solution Swabstick Povidone-Iodine Solution USP, 10%. The recall was initiated because the packaging laminate was reversed during manufacturing, allowing the product to come into direct contact with an aluminum layer. This contact caused a chemical reaction that reduces the effectiveness of the antiseptic and may cause the packaging to become warm or compromised. These swabsticks were distributed nationwide across the United States.

Risk

The chemical reaction between the iodine solution and the aluminum packaging causes the medication to become subpotent, meaning it may not effectively kill germs or prevent infection as intended. Additionally, the exothermic reaction creates heat that could potentially compromise the sterile barrier of the pouch.

What You Should Do

  1. Check your Betadine Solution Swabsticks (Povidone-Iodine Solution USP, 10%) for the following Lot numbers and Expiration dates: Lot 62823 (Exp. 12/31/18), Lot 64304 (Exp. 05/31/2019), Lot 64711 (Exp. 08/31/2019), or Lot 65915 (Exp. 12/31/2019).
  2. Look for the NDC number 67618-153-01 on the individual swabstick packaging to confirm it is the affected product.
  3. Immediately stop using any swabsticks from the affected lots and set them aside in a secure location.
  4. Contact your healthcare provider or pharmacist for guidance regarding alternative antiseptic products.
  5. Return any unused, affected swabsticks to the pharmacy or place of purchase for a refund.
  6. Contact Purdue Pharma, LP for further instructions regarding this recall or to report any issues.
  7. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Betadine Solution Swabstick Povidone-Iodine Solution USP, 10%
Model:
NDC 67618-153-01
Recall #: D-0070-2018
Lot Numbers:
62823 (Exp. 12/31/18)
64304 (Exp. 05/31/2019)
64711 (Exp. 08/31/2019)
65915 (Exp. 12/31/2019)
Date Ranges: Expires 12/31/18, Expires 05/31/2019, Expires 08/31/2019, Expires 12/31/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78229
Status: Resolved
Manufacturer: Purdue Pharma, LP
Sold By: Purdue Products LP
Manufactured In: United States
Units Affected: 3997 swabsticks
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 ยท 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.