American Regent recalls niCARdipine Hydrochloride injection: Lack of sterility assurance
American Regent recalls 10 vials of niCARdipine Hydrochloride injection (25 mg/10 mL) due to lack of sterility assurance. This could cause infections if used improperly.
Lower-risk recall
Lack of Assurance of Sterility.
Contact the company
What happened, in plain English
American Regent is recalling 10 vials of niCARdipine Hydrochloride injection (25 mg/10 mL) because they may not be sterile. Using these vials could lead to infections if they are not properly handled. Read more at govinfonow.com/recall/32673-american-regent-recalls-nicardipine-hydrochloride-injection-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/32673-american-regent-recalls-nicardipine-hydrochloride-injection-lack-of-sterility-assurance · Updated August 17, 2026 · FDA enforcement record: FDA #D-0503-2024
Cite this page
“American Regent recalls niCARdipine Hydrochloride injection: Lack of sterility assurance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32673-american-regent-recalls-nicardipine-hydrochloride-injection-lack-of-sterility-assurance. Based on FDA recall #D-0503-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0503-2024%22&limit=1).
Why it’s dangerous
The injection may not be sterile, which could lead to infections if used improperly. This is a risk for healthcare workers handling the product.
Who’s affected
Healthcare professionals who use this injection for intravenous treatment. Patients receiving this medication under medical supervision.
How to tell if you have this one
Look for vials labeled 'niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only'. They were manufactured by American Regent, Inc. in New Albany, OH with NDC 72572-470-10 and lot number 23087N0C0.
- Brand
American Regent- Category
Drug
What to do — step by step
Check Vial Label
Look for the label 'niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only' on the vial.
Where it went and when
Where it was distributed
Distributed in Utah.
FDA distribution: “UT only” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Utah.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0503-2024 (May 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0503-2024 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.