Ramipril Capsules USP recall (Hikma Pharmaceuticals USA INC.)
DrugClass IIOngoing
Summary: 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, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.. Reason: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
What is being 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.
Why
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the United States
How to tell if yours is affected
a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0831-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 24, 2026 |
| Reported | September 2, 2026 |
| Company | Hikma Pharmaceuticals USA INC. |
| Company location | Columbus, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | a) 25,970 bottles; b) 2,384 bottles |
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