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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88997

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

Open FDA event record

Event summary

Timeline bucket
November 04, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Amneal Pharmaceuticals of New York, 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

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

Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86

D-0233-2022
Recall number
D-0233-2022
Initiated
November 04, 2021
Classification
Class II
Status
Terminated
Quantity
7,766 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.

Code information

Lot #: 07040001A, exp. date 02/2022

Distribution pattern

Product was distributed nationwide within the United States

drug · product 2 of 2

Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86

D-0234-2022
Recall number
D-0234-2022
Initiated
November 04, 2021
Classification
Class II
Status
Terminated
Quantity
15,88 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.

Code information

Lot #: 07030002A, exp. date 02/2022

Distribution pattern

Product was distributed nationwide within the United States