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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98241

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

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Event summary

Timeline bucket
December 30, 2025
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
SUN PHARMACEUTICAL INDUSTRIES 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

Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4

D-0256-2026
Recall number
D-0256-2026
Initiated
December 30, 2025
Classification
Class III
Status
Ongoing
Quantity
24,624 bottles

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 Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

Code information

Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027

Distribution pattern

Nationwide within the USA

Field note

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