Ramipril Capsules USP, 10 mg recall
Hikma Pharmaceuticals USA INC. recalled Ramipril Capsules USP, 10 mg on September 2, 2026 because of failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). It was sold nationwide.
Why it was recalled
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
What's 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.
Quantity: a) 25,970 bottles; b) 2,384 bottles
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Hikma Pharmaceuticals USA INC., Columbus, OH
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Nationwide within the United States - Status
- Ongoing
- Recall number
- D-0831-2026
- Source
- U.S. Food and Drug Administration
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