Class IIDrug
Ramipril Capsules USP recall
Summary
Hikma Pharmaceuticals USA INC. is recalling Ramipril Capsules USP (drug). According to the FDA report, the reason is: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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).
- Lot / code info
- a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
- Quantity
- a) 25,970 bottles; b) 2,384 bottles
- Distribution
- Nationwide within the United States
- Recalling company
- Hikma Pharmaceuticals USA INC., Columbus, OH United States
- Recall started
- August 24, 2026
- FDA report date
- September 2, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0831-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Hikma Pharmaceuticals USA INC.) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.