niCARdipine Hydrochloride Injection recall
FDA recall D-0399-2025 · initiated Apr 18, 2025
American Regent, Inc. recalled niCARdipine Hydrochloride Injection in Apr 2025 — an FDA Class II recall (D-0399-2025) because Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 7,249 (cartons of 10 x 10 mL vials)
Details
- 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]
- Recalling company
- American Regent, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 18, 2025
- FDA report date
- May 7, 2025
Frequently asked
- Was niCARdipine Hydrochloride Injection recalled?
- American Regent, Inc. recalled niCARdipine Hydrochloride Injection in Apr 2025 — an FDA Class II recall (D-0399-2025) because Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was niCARdipine Hydrochloride Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0399-2025 was: Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
- Is a recalled niCARdipine Hydrochloride Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of niCARdipine Hydrochloride Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0399-2025.