Hikma Pharmaceuticals USA INC. Ramipril Capsules USP, 10 mg Recall
Announced 2026-09-02 · FDA
Two lots of Ramipril Capsules USP, 10 mg, were recalled due to failing impurity/degradation specifications for dicyclohexylurea (DCU). The recall affects 28,354 bottles nationwide (Lot AC5470A exp July 2027 and Lot AC5470B exp July 2027).
| Brand | Hikma Pharmaceuticals USA INC. |
|---|---|
| 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. |
| Reason | Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). |
| Severity | moderate |
| Units affected | 25970 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use Ramipril capsules from the affected lots AC5470A or AC5470B.
- Check your bottle’s lot number and expiration date; if it matches, contact your pharmacy or Hikma/Exelan for recall instructions.
- Consult your healthcare provider if you have concerns or if you have been taking these tablets.
- Watch for further recall updates from the FDA and the manufacturer for guidance on return or replacement.
How to identify the recalled item
| Lot / date codes | a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027 |
|---|---|
| Lot / date codes | a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.