Drug recall: Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi…
Class II FDA enforcement event 68793. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Daiichi Sankyo Pharma Development started this drug recall on 12 Jul 2014. The firm address in the FDA record is in Edison, NJ. FDA put the recall in Class II. FDA event 68793 has 8 product records. The first FDA enforcement report date is 6 Aug 2014. The record gives the status Terminated, with the termination date 16 Mar 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide
Recalling firm
Daiichi Sankyo Pharma Development, Edison, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
8 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1501-2014 | 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 | 5 bottles | Class II | Terminated | 6 Aug 2014 |
| D-1502-2014 | 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 | 262 bottles | Class II | Terminated | 6 Aug 2014 |
| D-1503-2014 | 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 | 108 bottles | Class II | Terminated | 6 Aug 2014 |
| D-1504-2014 | 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 | Class II | Terminated | 6 Aug 2014 | |
| D-1505-2014 | Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18 | 68 bottles | Class II | Terminated | 6 Aug 2014 |
| D-1506-2014 | 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 | Class II | Terminated | 6 Aug 2014 | |
| D-1507-2014 | 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 | 86 bottles | Class II | Terminated | 6 Aug 2014 |
| D-1508-2014 | 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 | Class II | Terminated | 6 Aug 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2014
- 313
- Share of these events in Class II
- 58%
- Product records in this event
- 8
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-1501-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 68793. https://recallregister.com/fda/ii/68793/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide
- What quantity of product is in FDA event 68793?
- The event has 8 product records. The first record gives this quantity:
5 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2014 have the same class?
- 58% of the 313 drug events that started in 2014 are in Class II.