FDA Drugs recall ·
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules ( recall
- Recall number
- D-0831-2026
- Date
- (initiated August 24, 2026)
- Company / brand
- Hikma Pharmaceuticals USA INC.
1809 Wilson Rd, Columbus, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- a) 25,970 bottles; b) 2,384 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
Distribution
Nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0831-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.