The Recall Desk
ModerateFDA (Drugs)·D-1502-2014·Announced 2014-08-06

Daiichi Sankyo Recalls Benicar Tablets Due to Temperature Abuse During Shipping

Daiichi Sankyo is recalling 262 bottles of Benicar 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 involves 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 262 bottles of Benicar Tablets (olmesartan medoxomil) 20 mg, in 30 and 90-count packages. The recall involves specific lots: Lot #0002055 (30 count, expiration 11/30/2016) and Lot #0002063 (90 count, expiration 12/31/2016). The products were distributed nationwide.

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 of the medication.

Consumers who have these specific lots of Benicar Tablets should stop using them and contact their healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
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
Manufacturer
Daiichi Sankyo Pharma Development
Category
Drug — Prescription Medication
Hazard
Affected units
262

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 #0002055 Exp - 11/30/2016
  • 90 count - Lot #0002063 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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