Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE… — Class III drug recall D-0134-2017
Terminated recall by Taro Pharmaceuticals U.S.A., Inc., reported 2016-11-16, distributed nationwide. Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
| Recall number | D-0134-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, United States |
| Recall initiated | 2016-05-26 |
| Classified | 2016-11-10 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2018-06-06 |
| Distributed | Nationwide (US) |
| Quantity | 17,100 kits |
| Reason classes | potency, specification failure |
| NDC | 51672-2125-05, 51672-2126-00 |
| Lot numbers | E601, E602, E603, E604, E608, E609, E610, E611 |
| Expiration dates | 2017-09-20, 2017-10-20 |
Product
Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC
Reason for recall
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0134-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.