American Regent recalls niCARdipine Hydrochloride Injection: Risk of contamination
American Regent recalls certain niCARdipine Hydrochloride Injection vials due to potential contamination from leakage around the vial neck. This could lead to lack of sterility assurance in medical use.
Lower-risk recall
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Contact the company
What happened, in plain English
American Regent has recalled specific niCARdipine Hydrochloride Injection vials because leakage around the neck may cause contamination. This poses a risk to patients receiving the medication. Read more at govinfonow.com/recall/32129-american-regent-recalls-nicardipine-hydrochloride-injection-risk-of-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/32129-american-regent-recalls-nicardipine-hydrochloride-injection-risk-of-contamination · Updated August 17, 2026 · FDA enforcement record: FDA #D-0398-2025
Cite this page
“American Regent recalls niCARdipine Hydrochloride Injection: Risk of contamination.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32129-american-regent-recalls-nicardipine-hydrochloride-injection-risk-of-contamination. Based on FDA recall #D-0398-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0398-2025%22&limit=1).
Why it’s dangerous
Leakage around the vial neck could allow contaminants to enter the injection, potentially causing infection or other complications. This is a sterility issue that affects medical use.
Who’s affected
Patients prescribed this medication by a healthcare provider. Those using the product for medical treatment are most at risk.
How to tell if you have this one
Check for vials labeled 'niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only'. The product was manufactured for specific lots with expiry dates listed in the recall notice.
- Brand
American Regent- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0398-2025 | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.; Lots, expiry: Lot 24025N0C0, 6/30/2025; Lot 24115N0C0, 10/31/2025; Lot 24116N0C0, 3/31/2026; Lot 24160N0C0, 12/31/2025; Lot 24217N0C0, 01/31/2026; Lot 24288N0C0, 04/30/2026; Lot 24331N0C0, 5/31/2026 | 29,777 (cartons of 10 x 10mL vials) | 72572-470-01, 72572-470-10 |
| D-0399-2025 | 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]; Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026; | 7,249 (cartons of 10 x 10 mL vials) | 0517-0735-01, 0517-0735-10 |
What to do — step by step
Check Product Details
Identify the vial by its label and lot numbers: 24025N0C0 (expiring 6/30/2025), 24115N0C0 (10/31/2025), 24116N0C0 (3/31/2026), 24160N0C0 (12/31/2025), 24217N0C0 (01/31/2026), 24288N0C0 (04/30/2026), 24331N0C0 (5/31/2026).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0398-2025 (April 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0398-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.