Recall events
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Event 71418
Event summary
Timeline bucket May 29, 2015
Product types Drug
Classifications Class II
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
Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9
D-1212-2015
Recall number D-1212-2015
Initiated May 29, 2015
Classification Class II
Status Terminated
Quantity 45,708 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Content Uniformity Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Code information Lot #: KP4726, Exp date 9/2015
Distribution pattern Nationwide, Hawaii and Puerto Rico
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[6030]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 4
Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3162-9
D-1213-2015
Recall number D-1213-2015
Initiated May 29, 2015
Classification Class II
Status Terminated
Quantity 23,178 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Content Uniformity Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Code information Lot #: KT3819, Exp 11/2015; Lot #: KT3821, Exp 11/2015
Distribution pattern Nationwide, Hawaii and Puerto Rico
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[6049]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 4
Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3161-9
D-1214-2015
Recall number D-1214-2015
Initiated May 29, 2015
Classification Class II
Status Terminated
Quantity 23,076 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Content Uniformity Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Code information Lot #: KN1449, Exp 06/2015
Distribution pattern Nationwide, Hawaii and Puerto Rico
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[6754]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 4
Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India, NDC 60505-0209-1
D-1215-2015
Recall number D-1215-2015
Initiated May 29, 2015
Classification Class II
Status Terminated
Quantity 4,584 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Content Uniformity Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Code information Lot #: KP4529, Exp 10/2015
Distribution pattern Nationwide, Hawaii and Puerto Rico
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[6296]
FDA event record
· Exact recall-number query on openFDA
