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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97431

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

Open FDA event record

Event summary

Timeline bucket
August 13, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Sandoz Inc

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

Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ, NDC# 0781-6186-67, Carton NDC# 0781-6186-67

D-0626-2025
Recall number
D-0626-2025
Initiated
August 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Sandoz Inc
Quantity
1,680 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Temperature Abuse

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Temperature Abuse

Code information

Lot # VNF35A, Exp.08/31/2026

Distribution pattern

Product was distributed to one consignee in CA.