Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68813

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

Open FDA event record

Event summary

Timeline bucket
July 14, 2014
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Wockhardt Usa 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

buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.

D-1513-2014
Recall number
D-1513-2014
Initiated
July 14, 2014
Classification
Class III
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
840 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 Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.

Code information

Lot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14

Distribution pattern

Nationwide