Exact FDA event identifier

Event 82065

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

Open FDA event record

Event summary

Timeline bucket: February 06, 2019
Product types: Drug
Classifications: Class III
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

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

Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.

D-0995-2019

Recall number: D-0995-2019
Initiated: February 06, 2019
Classification: Class III
Status: Terminated
Recalling firm: Dr. Reddy's Laboratories, Inc.
Quantity: 40,592, 90 and 1,000 count bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.

Code information

Lot #: a) C800589, Exp 5/2019; C706058, Exp 03/2019 Lot #: b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019.

Distribution pattern

Distributed Nationwide in the USA