FDA recall, , Moderate risk
Exelan Pharmaceuticals Ramipril Capsules USP
Ramipril Capsules USP, 10 mg, failed impurity specifications.
Summary by Recall Canary from the FDA notice
What happened
Hikma Pharmaceuticals USA INC., of Columbus, Ohio, recalled Ramipril Capsules USP, 10 mg, after an out-of-specification result for a process impurity, dicyclohexylurea (DCU), was obtained. The product was packaged in 100 Capsules and 500 Capsules bottles, manufactured for Exelan Pharmaceuticals, Inc., of Boca Raton, FL, and manufactured by West-Ward Columbus Inc., of Columbus, OH.
The recall began on August 24, 2026, and was added to the FDA's Enforcement Report on August 26, 2026. The product was distributed nationwide within the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its NDC and lot code are listed under that product.
An NDC (National Drug Code) is usually printed on the drug's label.
Ramipril Capsules USP, 10 mg
- NDC
- 76282-673-01
- 76282-673-05
- Lot code
- AC5470A
- AC5470B
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Hikma Pharmaceuticals USA INC.Columbus, Ohio
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99711
- Recall number
- D-0831-2026
- Quantity recalled
- a) 25,970 bottles; b) 2,384 bottles
All recalls from Hikma Pharmaceuticals USA INC.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
