Recall events
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Event 68793
Event summary
Timeline bucket July 12, 2014
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Daiichi Sankyo Pharma Development
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
8 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 8
Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30
D-1501-2014
Recall number D-1501-2014
Initiated July 12, 2014
Classification Class II
Status Terminated
Quantity 5 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Code information Lot #213655B Exp - 12/31/2017
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[14887]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 8
Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90
D-1502-2014
Recall number D-1502-2014
Initiated July 12, 2014
Classification Class II
Status Terminated
Quantity 262 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Code information 30 count - Lot #0002055 Exp - 11/30/2016; 90 count - Lot #0002063 Exp - 12/31/2016
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[5439]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 8
Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30
D-1503-2014
Recall number D-1503-2014
Initiated July 12, 2014
Classification Class II
Status Terminated
Quantity 108 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Code information Lot #0002106 Exp - 11/30/2016
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[5457]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 8
Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30
D-1504-2014
Recall number D-1504-2014
Initiated July 12, 2014
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Code information Lot #211836 Exp - 11/30/2016
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[13598]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 8
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18
D-1505-2014
Recall number D-1505-2014
Initiated July 12, 2014
Classification Class II
Status Terminated
Quantity 68 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Code information Lot NVWG Exp - 11/30/2016
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[16930]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 8
Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90
D-1506-2014
Recall number D-1506-2014
Initiated July 12, 2014
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Code information 30 count - Lot #0002096 Exp - 12/31/2016; 90 count - Lot #0002058 Exp -12/31/2016
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[5236]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 8
Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30
D-1507-2014
Recall number D-1507-2014
Initiated July 12, 2014
Classification Class II
Status Terminated
Quantity 86 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Code information Lot #0002073 Exp - 12/31/2016
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[5248]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 8
Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90
D-1508-2014
Recall number D-1508-2014
Initiated July 12, 2014
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Code information 30 count/Lot #0002108 Exp - 12/31/2016; 90 count/Lot #0002078 Exp - 12/31/2016
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[5342]
FDA event record
· Exact recall-number query on openFDA
