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Use caution Drug recall · FDA · Published May 26, 2016

Kamedis Dandruff Recall: Subpotent Zinc Pyrithione

Taro Pharmaceuticals recalls Kamedis Bio-Herbal Dandruff Care kits due to subpotent active ingredient levels. Check your lot numbers and expiration dates.

🇺🇸 FDA recall #D-0134-2017DrugKamedis ›
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Recalling firmTaro Pharmaceuticals U.S.A., Inc.3 Skyline Dr · Hawthorne, NY 10532-2174
✎ GovInfoNow plain-language explainer

What happened, in plain English

Taro Pharmaceuticals U.S.A., Inc. is recalling specific lots of the Kamedis Bio-Herbal Dandruff Care Therapeutic 2-Step System because the active ingredient, zinc pyrithione, was found to be subpotent (out of specification). This means the product may not work as intended for treating dandruff. The recall affects approximately 17,100 kits distributed nationwide. Read more at govinfonow.com/recall/42600-kamedis-dandruff-recall-subpotent-zinc-pyrithione.

Source Summary by GovInfoNow · govinfonow.com/recall/42600-kamedis-dandruff-recall-subpotent-zinc-pyrithione · Updated October 9, 2026 · FDA enforcement record: FDA #D-0134-2017

Cite this page

“Kamedis Dandruff Recall: Subpotent Zinc Pyrithione.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42600-kamedis-dandruff-recall-subpotent-zinc-pyrithione. Based on FDA recall #D-0134-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0134-2017%22&limit=1).

Why it’s dangerous

The hazard is that the assay values for the active ingredient, zinc pyrithione, were out of specification during stability testing. This results in a subpotent drug, meaning the concentration of the active ingredient may be lower than labeled, potentially rendering the treatment ineffective for its intended purpose.

Who’s affected

Consumers who purchased the Kamedis Bio-Herbal Dandruff Care Therapeutic 2-Step System (Step 1 and Step 2) from anywhere in the United States. Individuals relying on this product for effective dandruff treatment are most at risk of it not working properly.

How to tell if you have this one

Look for the product name 'Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM'. Check the NDC numbers: Step 1 is NDC 51672-2126-0 and Step 2 is NDC 51672-2125-5. Affected lots are E601, E602, E603, E604, E608, E609 (Expire September 2017) and E610, E611 (Expire October 2017).

  • Brand
    Kamedis
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Product Details

    Verify if your kit matches the affected NDC numbers and lot numbers listed in the recall record.

  2. Discontinue Use If Affected

    If you have one of the recalled lots, stop using the product as it may not provide the expected therapeutic benefit.

  3. Contact Manufacturer for Remedy

    The recall record does not specify a remedy or return process; contact Taro Pharmaceuticals U.S.A., Inc. directly for further instructions.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “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 2 years after the firm started it.

1. Firm started the recall: May 26, 201612. FDA classified it Class III: Nov 10, 201623. Published in FDA’s Enforcement Report: Nov 16, 201634. FDA terminated the recall: Jun 6, 2018420162018
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. 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-0134-2017 (May 26, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0134-2017 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA