CLASS II ONGOING Drug recall · Reported 27 Mar 2024 · FDA Enforcement Report
Nicardipine Hydrochloride Injection, USP 25mg/mL 5 mg/mL) vials recalled
Eugia US is recalling Nicardipine Hydrochloride Injection, USP 25mg/mL 5 mg/mL) vials, distributed nationwide in the US. The recall was initiated on 20 Feb 2024 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-0391-2024
- FDA event ID
- 94073
- Recalling firm
- Eugia US, East Windsor, NJ
- Manufacturer
- Eugia US LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Feb 2024
- FDA classified
- 19 Mar 2024
- Reported
- 27 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 20 Feb 2024 | Recall initiated by company | |
| 19 Mar 2024 | Classified by FDA | +28 days |
| 27 Mar 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Nicardipine Hydrochloride Injection, USP 25mg/mL 5 mg/mL) vials recalled?
Yes. Eugia US recalled Nicardipine Hydrochloride Injection, USP 25mg/mL 5 mg/mL) vials on 20 Feb 2024. The recall is Class II and its status is Ongoing. Recall number D-0391-2024.
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Which lots are affected?
Lot #: 3NC22019, Exp. Date 2/24
Where was it sold?
Nationwide within the United States
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Drug | CLASS III | Lidocaine HCl Injection, USP 2%, 40 mg recalled by Eugia USLidolog Kit | Eugia US | Other | Nationwide |
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Other Nicardipine recalls
All 9| 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/ 5 mg/mL) recalledNicardipine Hydrochloride | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection recalled by American RegentNicardipine Hydrochloride | American Regent | Sterility | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection recalled by American RegentNicardipine Hydrochloride | American Regent | Sterility | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection, USP, 25 mg/ 5 mg/mL) recalledNicardipine Hydrochloride | American Regent | Sterility | UT |