Food, drugs, devices › Taro Pharmaceuticals U.S.A., Inc.
Drug recall: Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay,
FDA enforcement event 89241 is a drug recall by Taro Pharmaceuticals U.S.A., Inc. of Hawthorne, NY, initiated 15 Dec 2021 and classified Class I, with 1 product record.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 19% of the 299 drug enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 4 Dec 2023. 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
"Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria"
Distribution
"Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0375-2022 | Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3 | 96 tubes | Class I | Terminated | 19 Jan 2022 |
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: "Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Dec 2023. "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.