FDA Recall D-0472-2025

Eugia US LLC · East Windsor, NJ

Class II Ongoing 350 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25

Lot / code: Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025

Quantity: 48,000 vials

Reason for recall

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.

Recall record

Recall number: D-0472-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-05-29
Classified by FDA Center: 2025-06-18
FDA published: 2025-06-25
Recalling firm: Eugia US LLC
Firm location: East Windsor, NJ

Drug identification

Brand name(s): GENTAMICIN
Generic name(s): GENTAMICIN
Manufacturer(s): Eugia US LLC
NDC(s): 55150-401
Route(s): INTRAMUSCULAR, INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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