Exact FDA event identifier

Event 74326

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

Event summary

Timeline bucket: May 25, 2016
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Sandoz 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01

D-1036-2016

Recall number: D-1036-2016
Initiated: May 25, 2016
Classification: Class III
Status: Terminated
Recalling firm: Sandoz Inc
Quantity: 3,048 bottles ( 304,800 tablets)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Package Insert

Code information

Lot # FC1960; Exp.: 02/18

Distribution pattern

Nationwide