Daiichi Sankyo Pharma Development Benicar HCT Tablets Recall

Why it was recalled

Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Product description

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

Lot numbers, UPCs & expiration codes

Lot #0002106 Exp - 11/30/2016

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1503-2014
Classification: Class II
Status: Terminated
Recall initiated: Jul 12, 2014
FDA report date: Aug 6, 2014
Quantity: 108 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Daiichi Sankyo Pharma Development

Original FDA data

Every field from FDA enforcement report D-1503-2014, exactly as published.

Show all FDA fields

City: Edison
State: NJ
Status: Terminated
Country: United States
Event ID: 68793
Address: 399 Thornall St
Code information: Lot #0002106 Exp - 11/30/2016
Postal code: 08837-2236
Report date: Aug 6, 2014
Product type: Drugs
Recall number: D-1503-2014
Classification: Class II
Recalling firm: Daiichi Sankyo Pharma Development
Product quantity: 108 bottles
Termination date: Mar 16, 2015
Reason for recall: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide
Recall initiation date: Jul 12, 2014
Initial firm notification: Telephone
Center classification date: Jul 31, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1503-2014, published Aug 6, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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