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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96680

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

Open FDA event record

Event summary

Timeline bucket
April 10, 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

Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01

D-0363-2025
Recall number
D-0363-2025
Initiated
April 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Eugia US LLC
Quantity
36,816 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Code information

Lot #: 1TC24075A, Exp 11/30/2026.

Distribution pattern

Nationwide USA