Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76543

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

Open FDA event record

Event summary

Timeline bucket
January 05, 2017
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

Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, Gujarat, India, NDC 47335-956-88.

D-0502-2017
Recall number
D-0502-2017
Initiated
January 05, 2017
Classification
Class II
Status
Terminated
Quantity
22,915 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.

Code information

Lot #: JKR5219A, JKR5200A, JKR5220A, JKR5221A, JKR5222A, Exp 03/18

Distribution pattern

Nationwide in the USA and Puerto Rico.