Home/Recalls/FDA-D-0831-2026
FDA DrugsClass II

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.

Published: September 2, 2026Recall ID: D-0831-2026Category: drugsCountry: US
US
PharmaceuticalFDA DrugsUSUS

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.

Recalling Firm: Hikma Pharmaceuticals USA INC.

Reason for Recall / Hazard

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

Product Description & Identification

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.

Affected Products

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.

Additional Source Details

FieldValue
CityColumbus
StateOH
Openfda › Nui › 1N0000175562
Openfda › Nui › 2N0000000181
Openfda › Upc › 10376282670010
Openfda › Upc › 20376282672014
Openfda › Upc › 30376282673011
Openfda › UniiL35JN3I7SJ
Openfda › RouteORAL
Openfda › Rxcui › 1198188
Openfda › Rxcui › 2198189
Openfda › Rxcui › 3261962
Openfda › Rxcui › 4845488
Openfda › Spl id37481fc5-771f-4dc7-aa06-6913ab75d485
Openfda › Brand nameRAMIPRIL
Openfda › Spl set id1e1dfacf-b831-4743-a874-9a5e5ef8a120
Openfda › Package ndc › 176282-670-01
Openfda › Package ndc › 276282-671-01
Openfda › Package ndc › 376282-671-05
Openfda › Package ndc › 476282-672-01
Openfda › Package ndc › 576282-672-05
Openfda › Package ndc › 676282-673-01
Openfda › Package ndc › 776282-673-05
Openfda › Product ndc › 176282-670
Openfda › Product ndc › 276282-671
Openfda › Product ndc › 376282-672
Openfda › Product ndc › 476282-673
Openfda › Generic nameRAMIPRIL
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Substance nameRAMIPRIL
Openfda › Pharm class epcAngiotensin Converting Enzyme Inhibitor [EPC]
Openfda › Pharm class moaAngiotensin-converting Enzyme Inhibitors [MoA]
Openfda › Manufacturer nameExelan Pharmaceuticals, Inc.
Openfda › Application numberANDA077900
Openfda › Is original packagertrue
Event id99711
Address 11809 Wilson Rd
Address 2N/A
Code infoa) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
Postal code43228-9579
Report date20260902
Product typeDrugs
Product quantitya) 25,970 bottles; b) 2,384 bottles
Reason for recallFailed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260824
Initial firm notificationLetter
Center classification date20260903

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Overview

  • Recalling FirmHikma Pharmaceuticals USA INC.
  • StatusOngoing
  • Risk LevelClass II
  • DistributionNationwide within the United States
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: Hikma Pharmaceuticals USA INC. - 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.

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Spread the WordRamipril 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.

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