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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75349

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 13, 2016
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Taro Pharmaceuticals, 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

2 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 2

Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7

D-0116-2017
Recall number
D-0116-2017
Initiated
September 13, 2016
Classification
Class II
Status
Terminated
Quantity
15,576 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Stability Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Code information

Lot #: B5093-18608, B5094-18608, Exp. Jan 2017; Lot #: C5141-18954, C5142-18954, E5109-19625, Exp . Feb 2017

Distribution pattern

US & Puerto Rico

drug · product 2 of 2

Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1271-7

D-0117-2017
Recall number
D-0117-2017
Initiated
September 13, 2016
Classification
Class II
Status
Terminated
Quantity
6,756 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Stability Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Code information

Lot #: E0598-19624, E5099-19624, Exp. Jan 2017

Distribution pattern

US & Puerto Rico