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Class II · ModerateActive recall

Ramipril

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numbera) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byWest-Ward Columbus Inc., Columbus, OH 43228
Brand nameRAMIPRIL
Generic nameRAMIPRIL
Active ingredient(s)RAMIPRIL
Distributed by / forExelan Pharmaceuticals, Inc., Boca Raton, FL 33432
NDC76282-673-01
Show the full FDA record
Full product labelRamipril 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.
Recalling firmHikma Pharmaceuticals USA INC.
DistributionNationwide within the United States
Quantitya) 25,970 bottles; b) 2,384 bottles
Recall initiated2026-08-24
Report date2026-09-02
Recall completed—
Recall numberD-0831-2026
ClassificationClass II
FDA statusOngoing
Origin on fileColumbus OH United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.