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Hikma Pharmaceuticals USA INC. Recall

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, Manufa

Updated August 24, 2026

Hikma Pharmaceuticals USA INC. is recalling 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, Manufa. Hazard: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

Is the Hikma Pharmaceuticals USA INC. recalled? Yes. This product was recalled by FDA on August 24, 2026. Details below.

What is recalled

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.

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

Brands affected

Hikma Pharmaceuticals USA INC.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0831-2026
Classification
Class II
Recalled
August 24, 2026
Read the official notice

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