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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71374

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

Open FDA event record

Event summary

Timeline bucket
May 22, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Dr. Reddy's Laboratories, 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

Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India

D-1135-2015
Recall number
D-1135-2015
Initiated
May 22, 2015
Classification
Class II
Status
Terminated
Quantity
100 count 7479; 500 count - 2544

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications; exceeded specification at the 9 hour time point

Code information

100 count bottle - Lot #C307859, exp 09/2015; 500 count bottle - Lot #C307859 and Lot# C307812, exp 09/2015

Distribution pattern

Nationwide

drug · product 2 of 2

Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01

D-1136-2015
Recall number
D-1136-2015
Initiated
May 22, 2015
Classification
Class II
Status
Terminated
Quantity
5,160 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications; exceeded specification at the 9 hour time point

Code information

Lot #C308195, exp 10/2015

Distribution pattern

Nationwide