Hikma Pharmaceuticals recall: Ramipril Capsules USP
Hikma Pharmaceuticals USA INC. is recalling Ramipril Capsules USP – a) 25,970 bottles; b) 2,384 bottles. The U.S. Food and Drug Administration published the recall on September 2, 2026; it began on August 24, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Ramipril Capsules USP |
| Brand | Hikma Pharmaceuticals |
| Company | Hikma Pharmaceuticals USA INC. |
| Type | Drugs |
| Classification | Class II |
| Recall date | August 24, 2026 |
| Published by FDA | September 2, 2026 |
| Quantity | a) 25,970 bottles; b) 2,384 bottles |
| Recall ID | 99711 |
Recalled 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.
- FDA recall number
- D-0831-2026
- Codes, lots and dates
- a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
- Quantity
- a) 25,970 bottles; b) 2,384 bottles
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99711
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Columbus, OH, United States
Why it was recalled
The reason the FDA lists: “Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).”
Where it was sold
Nationwide. Distribution as the FDA records it: “Nationwide within the United States”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99711, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Hikma Pharmaceuticals Ramipril Capsules USP recalled?
Yes. Hikma Pharmaceuticals USA INC. recalled it on August 24, 2026; FDA published it September 2, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.