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 Foam
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective delivery system; product is not foaming or is coming out as liquid.
What was recalled
Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- NDC code
- 68462-625-27
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0619-2020
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.
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