Ramipril Capsules USP recall
FDA recall D-0831-2026 · initiated Aug 24, 2026
Hikma Pharmaceuticals USA INC. recalled Ramipril Capsules USP in Aug 2026 — an FDA Class II recall (D-0831-2026) because Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: a) 25,970 bottles; b) 2,384 bottles
Details
- Product
- 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 company
- Hikma Intl Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Aug 24, 2026
- FDA report date
- Sep 2, 2026
Frequently asked
- Was Ramipril Capsules USP recalled?
- Hikma Pharmaceuticals USA INC. recalled Ramipril Capsules USP in Aug 2026 — an FDA Class II recall (D-0831-2026) because Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Ramipril Capsules USP recalled?
- Per the FDA enforcement record, the reason for recall D-0831-2026 was: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
- Is a recalled Ramipril Capsules USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ramipril Capsules USP are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0831-2026.