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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96976

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 29, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Eugia US LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0472-2025
Recall number
D-0472-2025
Initiated
May 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Eugia US LLC
Quantity
48,000 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Nationwide in the USA