Food, drugs, devices › Taro Pharmaceuticals U.S.A., Inc.
Drug recall: Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHI
Taro Pharmaceuticals U.S.A., Inc. (Hawthorne, NY) initiated this drug recall on 26 May 2016; FDA lists 1 product record under event 74730, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 43% of the 288 drug enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 6 Jun 2018. Initiation: voluntary: firm initiated. Taro Pharmaceuticals U.S.A., Inc. has 21 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY.
Reason for recall
"Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0134-2017 | 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%… | 17,100 kits | Class III | Terminated | 16 Nov 2016 |
Context
Other enforcement events for Taro Pharmaceuticals U.S.A., Inc.
All 21 events for Taro Pharmaceuticals U.S.A., Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Jun 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.