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Ramipril Capsules USP 10 mg
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DRUG RECALLMODERATE

Ramipril Capsules USP 10 mg

Hikma recalls Ramipril Capsules USP 10 mg over a failed impurity (DCU) specification.

What to do

Consumers with the affected Ramipril Capsules USP, 10 mg, should stop using them and return them to the pharmacy or place of purchase for a refund or replacement. Contact Hikma Pharmaceuticals for further instructions.

Recalled
Listed
Updated
Recall No.
D-0831-2026
Agency
FDA
Firm
Hikma Pharmaceuticals USA INC.
Recall ID
99711
Status
ONGOING

Recall at a glance

Quantity recalled
a) 25,970 bottles; b) 2,384 bottles

Why it was recalled

Hikma Pharmaceuticals is recalling Ramipril Capsules USP, 10 mg, packaged in 100-count and ​500-count bottles, because a process impurity, dicyclohexylurea (DCU), failed impurities/degradation specifications. The product is Rx only and was manufactured for Exelan Pharmaceuticals by West-Ward Columbus Inc.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Ramipril Capsules USP

Lot code
AC5470A, 2027, AC5470B
Strength
10 mg
NDC / UPC
NDC 76282-673-01, NDC 76282-673-05

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Impurity or Degradation recalls

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Editorial summary by Recall Canary · summary updated 2026-09-04 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification