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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89678

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

Open FDA event record

Event summary

Timeline bucket
February 25, 2022
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Taro Pharmaceuticals U.S.A., 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

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1

D-0727-2022
Recall number
D-0727-2022
Initiated
February 25, 2022
Classification
Class III
Status
Terminated
Quantity
768 tubes

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 Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample

Code information

Lot #: AC33883, Exp. Date June 2023

Distribution pattern

Product was distributed to one retail consignee in NY.