Class II · Moderate risk Ongoing
Clobetasol Propionate Shampoo
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Clobetasol Propionate Ointment USP
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
What was recalled
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
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- NDC code
- 51672-1259-3
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0375-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Clobetasol recalls
See all
Class II · Moderate risk Ongoing
Clobetasol Propionate Ointment
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Clobetasol Propionate Cream
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk Terminated
Clobetasol propionate Cream USP
Reason Subpotent Drug: Low assay result observed during long-term stability testing.
Class II · Moderate risk Terminated
Clobetasol Propionate Lotion 0.05%
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.