The Recall Desk
ModerateFDA (Drugs)·D-0483-2021·Announced 2021-06-02

Cardinal Health Recalls Verapamil Hydrochloride Tablets Due to Temperature Excursions

Cardinal Health Inc. is recalling 513 bottles of Verapamil Hydrochloride Extended-Release Tablets 120 mg due to intermittent 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, which is a reasonable probability of 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 513 bottles of Verapamil Hydrochloride Extended-Release Tablets USP 120 mg. The product is identified by NDC 68462-292-01 and code 19205584. The tablets were manufactured by Glenmark Generics Ltd in India for Glenmark Generics Inc. in the United States.

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

The affected product was distributed in Florida, Georgia, and South Carolina. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.

The recalled product

Product
VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE)
Brand
VERAPAMIL HYDROCHLORIDE
Affected units
513

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)

  • 19205584

UPCs (4)

  • 0368462292013
  • 0368462293010
  • 0368462260012
  • 074301920558

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 →

Same brand · VERAPAMIL HYDROCHLORIDE