FDA Drugs recall ·
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL)… recall
- Recall number
- D-0399-2025
- Date
- (initiated April 18, 2025)
- Company / brand
- American Regent, Inc.
6610 New Albany Rd E, New Albany, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7,249 (cartons of 10 x 10 mL vials)
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
Why was it recalled?
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
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
Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;
Distribution
Nationwide in the USA
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-0399-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.