Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86736

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

Open FDA event record

Event summary

Timeline bucket
November 11, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Apotex Corp.

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

Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326

D-0106-2021
Recall number
D-0106-2021
Initiated
November 11, 2020
Classification
Class II
Status
Terminated
Recalling firm
Apotex Corp.
Quantity
a)552 bottles; b) 3192 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 Dissolution Specifications: Out of specification for dissolution.

Code information

a) PZ6716 Exp. 02/2021; b) PZ6715 Exp. 02/2021

Distribution pattern

Distributed Nationwide in the USA