Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88927

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

Open FDA event record

Event summary

Timeline bucket
October 22, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SUN PHARMACEUTICAL INDUSTRIES 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

Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.

D-0361-2022
Recall number
D-0361-2022
Initiated
October 22, 2021
Classification
Class II
Status
Terminated
Quantity
696 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.

Code information

Lot number: DNC0432A, expiration 01/2023

Distribution pattern

Nationwide in the USA