The Recall Desk
ModerateFDA (Drugs)·D-0461-2021·Announced 2021-06-02

Cardinal Health Recalls Valsartan Tablets Due to Temperature Excursions

Cardinal Health is recalling Valsartan 40 mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

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, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Cardinal Health Inc. is recalling Valsartan Tablets USP 40 mg, 30 scored tablets, prescription only. The product is identified by NDC 59746-360-30 and was manufactured by Jubilant Generics Ltd. in India. The recall involves 20 bottles of the medication.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. This condition may affect the stability or quality of the drug product.

The affected product was distributed in Florida, Georgia, and South Carolina. Patients and healthcare providers should check their inventory for the specific NDC and lot information provided in the recall notice. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund.

The recalled product

Product
VALSARTAN (VALSARTAN)
Brand
VALSARTAN
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
20

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)

  • VR120022A

UPCs (8)

  • 0359746363321
  • 0359746363307
  • 0359746361037
  • 0359746362034
  • 0359746360306
  • 0359746360030
  • 0359746361303
  • 0359746362300

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 →

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