The Recall Desk
ModerateFDA (Drugs)·D-0597-2021·Announced 2021-06-02

Cardinal Health Recalls Enalapril Maleate Tablets Due to Storage Temperature Excursions

Cardinal Health is recalling 10 bottles of Enalapril Maleate Tablets 2.5 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 and involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 10 bottles of Enalapril Maleate Tablets, USP 2.5 mg (NDC 64679-923-02). The recall is due to 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 DV10467.

Consumers and healthcare providers should check their inventory for this specific NDC and code. If found, the product should be quarantined and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal Health, NDC 64679-923-02
Affected units
10

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)

  • DV10467

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 →