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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76325

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

Open FDA event record

Event summary

Timeline bucket
December 22, 2016
Product types
Drug
Classifications
Class II
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

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

Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30

D-0474-2017
Recall number
D-0474-2017
Initiated
December 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Aurobindo Pharma USA Inc
Quantity
47,040 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.

Code information

Lot #: VI3716010-A, Exp. 04/2018

Distribution pattern

Nationwide in the US