Recall events
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Event 69546
Event summary
Timeline bucket October 16, 2014
Product types Drug
Classifications Class III
Statuses Terminated
Recalling firm wording Apotex 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
4 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 4
Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3
D-0241-2015
Recall number D-0241-2015
Initiated October 16, 2014
Classification Class III
Status Terminated
Quantity 13,177 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 Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Code information Lot #: KR3924, KR3926; Exp. 11/15
Distribution pattern Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[8659]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 4
Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
D-0242-2015
Recall number D-0242-2015
Initiated October 16, 2014
Classification Class III
Status Terminated
Quantity 18,493
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 Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Code information Lot # KR3933; Exp.10/15 Lot # KR3935, KR3934; Exp.11/15
Distribution pattern Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[6132]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 4
Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
D-0243-2015
Recall number D-0243-2015
Initiated October 16, 2014
Classification Class III
Status Terminated
Quantity 11,062 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 Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Code information Lot #: a) KR3943; Exp. 11/15 Lot #: b) KT6058, KT6060; Exp. Date 11/15
Distribution pattern Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[8321]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 4
Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
D-0244-2015
Recall number D-0244-2015
Initiated October 16, 2014
Classification Class III
Status Terminated
Quantity 22,710 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 Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Code information Lot #: a) KR3955; Exp. 10/15, KV0430, Exp. 11/15 Lot #: b) KT6063; Exp. 10/15
Distribution pattern Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[8762]
FDA event record
· Exact recall-number query on openFDA
