CLASS II ONGOING Drug recall · Reported 2 Sep 2026 · FDA Enforcement Report
Ramipril Capsules USP, 10 mg recalled by Hikma Pharmaceuticals USA
Hikma Pharmaceuticals USA is recalling Ramipril Capsules USP, 10 mg, distributed nationwide in the US. The recall was initiated on 24 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0831-2026
- FDA event ID
- 99711
- Recalling firm
- Hikma Pharmaceuticals USA, Columbus, OH
- Brand
- Ramipril
- Manufacturer
- Exelan Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Aug 2026
- FDA classified
- 3 Sep 2026
- Reported
- 2 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 24 Aug 2026 | Recall initiated by company | |
| 2 Sep 2026 | Published in enforcement report | +9 days |
| 3 Sep 2026 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Ramipril Capsules USP, 10 mg recalled?
Yes. Hikma Pharmaceuticals USA recalled Ramipril Capsules USP, 10 mg on 24 Aug 2026. The recall is Class II and its status is Ongoing. Recall number D-0831-2026.
Why was it recalled?
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Which lots are affected?
a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hikma Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Alendronate Sodium Oral Solution, 70 mg recalledAlendronate Sodium | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepam | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS I | Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen | Hikma Pharmaceuticals USA | Packaging Defects | OH, PR |
| Drug | CLASS II | Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200 | Hikma Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Lorazepam Injection, USP, 2mg/mL vial recalledLorazepam | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
Other Ramipril recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ramipril Capsules USP 5 mg, a) recalled by Lupin PharmaceuticalsRamipril | Lupin Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ramipril Capsules USP 5 mg, a) recalled by Lupin PharmaceuticalsRamipril | Lupin Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ramipril Capsules USP 10 mg, a) recalled by Lupin PharmaceuticalsRamipril | Lupin Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Ramipril Capsules, USP, 25 mg recalled by Actavis Laboratories, FL | Actavis Laboratories, FL | Other | Nationwide |