Reported Sep 2, 2026 · Ongoing · Updated Sep 16, 2026

Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05)…

Hikma Pharmaceuticals USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hikma Pharmaceuticals USA INC. · 1809 Wilson Rd · Columbus, OH · 43228-9579

Is this the product you have?

  • 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 forExelan Pharmaceuticals, Inc., Boca Raton, FL 33432
  • Manufactured byWest-Ward Columbus Inc., Columbus, OH 43228
Lot codes and dates
    • a) Lot #: AC5470A
    • Exp. Date July 2027 b) Lot #: AC5470B
    • Exp. Date July 2027
Amount recalled
a) 25,970 bottles; b) 2,384 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Notice updated Sep 3, 2026 · Data as of Sep 19, 6:19 PM UTC

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