The Recall Desk
ModerateFDA (Drugs)·D-0464-2021·Announced 2021-06-02

Cardinal Health Recalls Nadolol Tablets Due to Temperature Excursions

Cardinal Health Inc. is recalling 40 bottles of Nadolol 40 mg tablets 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 typically indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard involves storage conditions rather than a direct contamination or mislabeling of a common allergen.

Plain-English summary

Cardinal Health Inc. is recalling 40 bottles of Nadolol Tablets, USP 40 mg. The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.

The affected product is identified by the code NB100156 and NDC 69097-868-07. The tablets were distributed in Florida, Georgia, and South Carolina. The product was manufactured for Cipla USA Inc.

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

The recalled product

Product
NADOLOL (NADOLOL)
Brand
NADOLOL
Affected units
40

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)

  • NB100156

UPCs (3)

  • 0369097867072
  • 0369097869076
  • 0369097868079

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 →