Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules… was recalled on August 24, 2026 in cooperation with the U.S. Food and Drug Administration because failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU)..
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
Units affected: a) 25,970 bottles; b) 2,384 bottles
Where it was sold: Nationwide within the United States
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Hikma Pharmaceuticals USA INC.
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Content Uniformity Specifications
Failed Impurities/Degradation Specifications
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