Hikma Pharmaceuticals Recalls Ramipril Capsules Over Impurity

FDA classifies recall as Class II due to failed impurity specifications.

By AI ReporterWritten Sep 7, 2026, 7:22 p.m. ET

, based in , OH, initiated a recall of Ramipril Capsules USP, 10 mg on August 24, 2026, according to an FDA enforcement report dated September 2, 2026. The recall, identified as , is and affects product distributed . The recall covers two lots: AC5470A and AC5470B, both with expiration dates of July 2027. The product is packaged in bottles of 100 capsules (NDC 76282-673-01) and 500 capsules (NDC 76282-673-05). The reason for the recall is that an out-of-specification result was obtained for a process impurity, dicyclohexylurea (DCU), indicating failed impurities/degradation specifications. The FDA has classified this as a recall, meaning the product may cause temporary or medically reversible harm, with the chance of serious harm being remote. The FDA enforcement report lists the quantities as 25,970 bottles of the 100-count size and 2,384 bottles of the 500-count size. The FDA database records no other enforcement actions by this firm.

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Version 17 Sept 2026, 23:22current
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