The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1508-2014·Announced 2014-08-06

Daiichi Sankyo Recalls Benicar HCT Tablets Due to Temperature Abuse

Daiichi Sankyo is recalling specific lots of Benicar HCT tablets because they were not stored at controlled room temperature during shipping.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which typically involves a situation that may cause temporary or medically reversible health consequences. The hazard is a storage condition (temperature abuse) rather than a direct contamination or defect, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.

Plain-English summary

Daiichi Sankyo Pharma Development is recalling Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg. The affected products are available in 30-count and 90-count bottles and are distributed nationwide. The specific lots involved are Lot #0002108 (30 count) and Lot #0002078 (90 count), both with an expiration date of 12/31/2016.

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

Consumers and healthcare providers should check their inventory for these specific NDC numbers (65597-107-30 and 65597-107-90) and lot numbers. If found, the medication should be discontinued and returned to the pharmacy or supplier for replacement or refund.

The recalled product

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

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 (2)

  • 30 count/Lot #0002108 Exp - 12/31/2016
  • 90 count/Lot #0002078 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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