Ramipril Capsule
FDA Recall NDC 76282-671
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ramipril (NDC 76282-671). A significant event, classified as Class II, was initiated on Aug 24, 2026 by Exelan Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU)."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Aug 24, 2026
Sep 02, 2026
a) 25,970 bottles; b) 2,384 bottles
Recall Profile & Regulatory Data
Event ID
99711
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Hikma Pharmaceuticals USA INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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.
Batch or Lot Expiration Information
Lot# a)
Lot# : AC5470A, Exp. Date July 2027 b)
Lot# : AC5470B, Exp. Date July 2027
Affected Packages Involved in this Recall
76282-670-01Product
76282-671-01Product
76282-671-05Product
76282-672-01Product
76282-672-05Product
76282-673-01Product
76282-673-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
