FDAFDA · Food and drugs·Recall number D-0831-2026
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.
Published September 2, 2026 · Recall initiated: August 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- RAMIPRIL
- Manufacturer
- Hikma Pharmaceuticals USA INC.
- Distributor
- Nationwide within the United States
- UPC
- 0376282670010
- Lot
- a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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