Exact FDA event identifier

Event 65071

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

Open FDA event record

Event summary

Timeline bucket: April 09, 2013
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Aurobindo Pharma 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

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, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India

D-498-2013

Recall number: D-498-2013
Initiated: April 09, 2013
Classification: Class III
Status: Terminated
Recalling firm: Aurobindo Pharma USA Inc
Quantity: 1776 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Error

Potency or specification failure reason.potency_specification_failure · v1.0.0

Incorrect strength

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label

Code information

Lot KP3012001-A Exp.12/13 Lot KP3012002-A Exp.12/13

Distribution pattern

Nationwide