The Recall Desk
ModerateFDA (Drugs)·D-1507-2014·Announced 2014-08-06

Benicar HCT Tablets Recalled Due to Temperature Abuse During Shipping

Daiichi Sankyo is recalling 86 bottles of Benicar HCT 40 mg/12.5 mg 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 involves temperature abuse during shipping without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Daiichi Sankyo Pharma Development is recalling 86 bottles of Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg. The affected product is identified by Lot #0002073 and has an expiration date of 12/31/2016. The recall is limited to 30-count bottles, NDC 65597-106-30.

The recall was initiated because the products were not stored at Controlled Room Temperature as per USP guidelines during shipping. This temperature abuse may affect the quality and stability of the medication.

The affected product was distributed nationwide. Consumers who have this specific lot of Benicar HCT should contact their healthcare provider or pharmacist for guidance on whether to discontinue use or obtain a replacement.

The recalled product

Product
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
Manufacturer
Daiichi Sankyo Pharma Development
Category
Drug — Prescription Medication
Hazard
Affected units
86

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 #0002073 Exp - 12/31/2016

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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