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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71946

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 29, 2015
Product types
Drug
Classifications
Class II
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

2 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 2

Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.

D-1346-2015
Recall number
D-1346-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
1704 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Code information

Lot #: DM12700, Exp 09/15

Distribution pattern

Nationwide

drug · product 2 of 2

Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06.

D-1347-2015
Recall number
D-1347-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
3378 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Code information

Lot #: DM13219, Exp 10/15; DM13428, Exp 11/15

Distribution pattern

Nationwide