FirstAlerts

Lupin Pharmaceuticals Recalls Clobetasol Propionate Cream Over Content Uniformity Failure

FDA Class II recall of two lots of clobetasol propionate cream 0.05% due to failed content uniformity specifications.

By AI ReporterWritten Sep 7, 2026, 10:21 p.m. ET
of , Florida, initiated a voluntary recall of two lots of Clobetasol Propionate Cream USP, 0.05%, 60 g tubes, according to an FDA enforcement report dated September 2, 2026. The recall, identified as , was initiated on August 3, 2026, and is . The reason given is that the product The affected lots are KB00427 (exp. 4/30/2028) and KA00308 (exp. 10/31/2026). The product is packaged in 60-gram tubes, NDC 68180-956-04, and was distributed nationwide in the USA. A total of 5,082 tubes are involved. The FDA has classified this as a recall, meaning the product may cause temporary or medically reversible harm, and the chance of serious harm is remote. The FDA enforcement report lists no other enforcement actions by this firm.

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  1. Version 18 Sept 2026, 02:21current

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