The Recall Desk
ModerateFDA (Drugs)·D-1503-2014·Announced 2014-08-06

Benicar HCT Tablets Recalled for Temperature Abuse During Shipping

Daiichi Sankyo is recalling 108 bottles of Benicar HCT 20 mg/12.5 mg tablets because they were not stored at controlled room temperature during shipping.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a storage condition deviation (temperature abuse) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Daiichi Sankyo Pharma Development is recalling 108 bottles of Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles. The recall is due to temperature abuse, as the products were not stored at Controlled Room Temperature as per USP guidelines during shipping.

The affected product is identified by Lot #0002106 with an expiration date of 11/30/2016. The recall is classified as Class II by the FDA. The product was distributed nationwide.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
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
Manufacturer
Daiichi Sankyo Pharma Development
Category
Drug — Prescription Medication
Hazard
Affected units
108

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot #0002106 Exp - 11/30/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Daiichi Sankyo Pharma Development under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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