Why it was recalled
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Product description
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.
Lot numbers, UPCs & expiration codes
a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0831-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 24, 2026
- FDA report date
- Sep 2, 2026
- Quantity
- a) 25,970 bottles; b) 2,384 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Pharmaceuticals USA INC.
Original FDA data
Every field from FDA enforcement report D-0831-2026, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 99711
- Address
- 1809 Wilson Rd
- Code information
- a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
- Postal code
- 43228-9579
- Report date
- Sep 2, 2026
- Product type
- Drugs
- Recall number
- D-0831-2026
- Classification
- Class II
- Recalling firm
- Hikma Pharmaceuticals USA INC.
- Product quantity
- a) 25,970 bottles; b) 2,384 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 24, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 3, 2026