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Use caution Drug recall · FDA · Published February 20, 2024

Eugia Recalls Nicardipine Hydrochloride Injection Due to Impurities

Eugia US LLC recalls specific lots of Nicardipine Hydrochloride Injection vials due to failed impurity specifications. Check lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0391-2024DrugEugia US LLC ›
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Contact the company

Recalling firmEugia US LLC279 Princeton Hightstown Rd · East Windsor, NJ 08520-1401
✎ GovInfoNow plain-language explainer

Eugia US LLC is recalling Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) in 10 mL vials because the product failed organic impurity specifications. The recall affects 43,920 vials distributed nationwide by AuroMedics Pharma LLC. No specific remedy or action steps are currently listed in the record. Read more at govinfonow.com/recall/32803-eugia-recalls-nicardipine-hydrochloride-injection-due-to-impurities.

Source Summary by GovInfoNow · govinfonow.com/recall/32803-eugia-recalls-nicardipine-hydrochloride-injection-due-to-impurities · Updated October 9, 2026 · FDA enforcement record: FDA #D-0391-2024

Cite this page

“Eugia Recalls Nicardipine Hydrochloride Injection Due to Impurities.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32803-eugia-recalls-nicardipine-hydrochloride-injection-due-to-impurities. Based on FDA recall #D-0391-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0391-2024%22&limit=1).

Eugia US LLC, distributed by AuroMedics Pharma LLC, is recalling Nicardipine Hydrochloride Injection vials due to failed impurity specifications. The Food and Drug Administration announced the Class II recall on February 20, 2024.

How to tell if you have it

  • Brand: Eugia US LLC
  • Product: Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials
  • Distributed by: AuroMedics Pharma LLC
  • NDC: 55150-183-11
  • Lot #: 3NC22019
  • Exp. Date: 2/24
  • Quantity: 43,920 vials

The hazard

The product failed organic impurity specifications, according to the FDA. The agency classified the recall as Class II.

Context

GovInfoNow's records show Eugia US LLC has 14 other recalls on record since December 28, 2022. Other recent recalls of similar products include Eugia's May 18, 2026 Lidocaine injection recall for labeling issues and its May 29, 2025 Gentamicin Injection recall due to stability failure. Additional comparable actions involve Unichem's January 21, 2026 Bisoprolol/Hydrochlorothiazide Tablets recall for N-Nitroso impurity risk and Fresenius Kabi's May 14, 2026 Epinephrine Injection recall for failed impurities.

How to tell if you have this one

Look for Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) in 10 mL vials distributed by AuroMedics Pharma LLC. Identify the specific lot number 3NC22019 and expiration date of February 2024 on the packaging.

  • Brand
    Eugia US LLC
  • Category
    Drug
FDA recall event · 2 products

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 within the United States
Recall numberProduct, codes & lotsQuantityNDC
D-0390-2024Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10; Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24335,940 vials55150-183-01, 55150-183-10
D-0391-2024Nicardipine 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; Lot #: 3NC22019, Exp. Date 2/2443,920 vials55150-183-02, 55150-183-11
Based on the official FDA remedy

What to do — step by step

  1. Check Lot Numbers

    Verify if your vials match lot number 3NC22019 with an expiration date of February 2024.

  2. Contact Distributor

    Reach out to AuroMedics Pharma LLC for further instructions on how to handle the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 36 days after the firm started it.

1. Firm started the recall: Feb 20, 202412. FDA classified it Class II: Mar 19, 202423. Published in FDA’s Enforcement Report: Mar 27, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Who distributed the recalled product?

The product was distributed nationwide within the United States by AuroMedics Pharma LLC.

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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-0391-2024 (February 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0391-2024 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA