Clobetasol Propionate Cream USP
Failed content uniformity specifications.
Yes — there is an active recall. 4 ongoing FDA recalls mention Clobetasol (27 total). Check the affected lots below.
Most common reason: Stability / shelf life (11 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Clobetasol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Failed content uniformity specifications.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Subpotent Drug: Low assay result observed during long-term stability testing.
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
CGMP Deviations
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Superpotent and Subpotent; low and high assay results
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Lack of Processing Control
Defective delivery system; product is not foaming or is coming out as liquid.
Defective delivery system; product is not foaming or is coming out as liquid.
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Defective Container; complaints of leakage.
Failed Content Uniformity Specifications
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
Lack of Assurance of Sterility: There are also CGMP Deviations.
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