Food, drugs, devices › Taro Pharmaceuticals U.S.A., Inc.
Drug recall: Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israe
Taro Pharmaceuticals U.S.A., Inc. (Hawthorne, NY) initiated this drug recall on 21 Dec 2017; FDA lists 1 product record under event 79029, 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. 30% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 21 Sep 2020. 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
"Failed Content Uniformity Specifications"
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0249-2018 | Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3 | 27,792 tubes | Class III | Terminated | 7 Feb 2018 |
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: "Failed Content Uniformity Specifications"
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 21 Sep 2020. "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.