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Lower risk Drug recall · FDA · Published February 22, 2024

Eugia recalls Tobramycin injection due to stability issues

Eugia US LLC recalls Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package for potential stability issues. This product was manufactured in India and distributed to US pharmacies. Check your carton NDC 55150-470-06 and vial NDC 55150-470-01 for affected lots.

🇺🇸 FDA recall #D-0385-2024DrugEugia ›
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Recalling firmEugia US LLC279 Princeton Hightstown Rd · East Windsor, NJ 08520-1401
✎ GovInfoNow plain-language explainer

Eugia US LLC is recalling Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package because it failed stability tests. This means the product may not be safe for intravenous use as it could degrade over time. Read more at govinfonow.com/recall/32801-eugia-recalls-tobramycin-injection-due-to-stability-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/32801-eugia-recalls-tobramycin-injection-due-to-stability-issues · Updated August 17, 2026 · FDA enforcement record: FDA #D-0385-2024

Cite this page

“Eugia recalls Tobramycin injection due to stability issues.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32801-eugia-recalls-tobramycin-injection-due-to-stability-issues. Based on FDA recall #D-0385-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0385-2024%22&limit=1).

Eugia US LLC recalled Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package nationwide due to failed stability specifications, the FDA said on Feb. 22, 2024. The recall affects 1,160 vials distributed across the country.

How to tell if you have it

  • Brand: Eugia
  • Product: Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION
  • Carton NDC: 55150-470-06
  • Vial NDC: 55150-470-01
  • Lot codes: 3TB23001, 3TB23002
  • Expiration date: 04/30/2025
  • Quantity: 1,160 vials

The hazard

The product failed stability specifications because water determination results did not comply with the required specification. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Eugia US LLC has issued 14 other recalls since Dec. 28, 2022. Recent Eugia recalls include a Lidocaine injection recall on May 18, 2026, due to label scanning issues, and a Gentamicin Injection recall on May 29, 2025, for stability failure. Other recent recalls of similar products include Safecor Health Fluphenazine Elixir Recall (Aug. 13, 2026), Somerset Therapeutics Cisatracurium Besylate Injection Recall (Nov. 26, 2025), and Baxter Vancomycin Injection Recall (Aug. 6, 2026).

How to tell if you have this one

Check for carton NDC 55150-470-06 and vial NDC 55150-470-01. The affected lots are 3TB23001 and 3TB23002, expiring April 30, 2025.

  • Brand
    Eugia
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for carton NDC 55150-470-06 and vial NDC 55150-470-01 on the packaging.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

1. Firm started the recall: Feb 22, 202412. FDA classified it Class II: Mar 14, 202423. Published in FDA’s Enforcement Report: Mar 20, 202434. FDA terminated the recall: Dec 22, 2025420242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-0385-2024 (February 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0385-2024 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.
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