The Recall Desk
ModerateFDA (Drugs)·D-0468-2021·Announced 2021-06-02

Cardinal Health Recalls Benicar Tablets Due to Temperature Excursions

Cardinal Health Inc. is recalling 75 bottles of Benicar 40mg tablets due to intermittent exposure to temperature excursions during storage.

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 source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Cardinal Health Inc. is recalling 75 bottles of Benicar 40mg tablets (NDC/UPC 65597010430). The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected product was distributed in Florida, Georgia, and South Carolina. The specific code for the recalled product is 1703296.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.

The recalled product

Product
BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
75

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)

  • 1703296

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. 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 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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