CLASS II ONGOING Drug recall · Reported 7 May 2025 · FDA Enforcement Report
niCARdipine Hydrochloride Injection, USP, 25 mg recalled
American Regent is recalling niCARdipine Hydrochloride Injection, USP, 25 mg/ (2.5 mg/mL) Single Dose Vial, distributed nationwide in the US. The recall was initiated on 18 Apr 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0399-2025
- FDA event ID
- 96695
- Recalling firm
- American Regent, New Albany, OH
- Manufacturer
- American Regent, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Apr 2025
- FDA classified
- 1 May 2025
- Reported
- 7 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Apr 2025 | Recall initiated by company | |
| 1 May 2025 | Classified by FDA | +13 days |
| 7 May 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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]
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Which lots are affected?
Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96695This product is part of a recall event; the main page for the event is niCARdipine Hydrochloride Injection, USP, 25 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride | American Regent | Sterility | Nationwide |
More recalls from American Regent
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalledEpinephrine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Tralement (trace elements injection 4*, USP) recalled by American RegentTralement | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Selenious Acid Injection, USP 12 mcg/ (6 mcg/, For intravenous use recalledSelenious Acid | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American RegentAminocaproic Acid | American Regent | Particulate Matter | Nationwide |
Other Nicardipine recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cardene IV (Nicardipine Hydrochloride) recalled by Baxter HealthcareCardene Iv | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection, USP, 25 mg/ (2.5 mg/mL) recalledNicardipine Hydrochloride | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride | American Regent | Sterility | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride | American Regent | Sterility | UT |
| Drug | CLASS II | Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per Vial recalledNicardipine Hydrochloride | Eugia US | Potency & Assay | Nationwide |