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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90853

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

Open FDA event record

Event summary

Timeline bucket
August 23, 2022
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Leading Pharma, 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

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

ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01

D-1546-2022
Recall number
D-1546-2022
Initiated
August 23, 2022
Classification
Class III
Status
Terminated
Recalling firm
Leading Pharma, LLC
Quantity
960 bottles (100 capsules)

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

Code information

Lot#: B14221, Exp. Date 02/2023

Distribution pattern

Nationwide within the United States