The Recall Desk
ModerateFDA (Drugs)·D-0593-2021·Announced 2021-06-02

Cardinal Health Recalls Haloperidol Tablets Due to Temperature Excursions

Cardinal Health Inc. is recalling 35 bottles of Haloperidol 20mg 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 hazard involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Cardinal Health Inc. is recalling 35 bottles of Haloperidol 20mg tablets, USP, 100-count bottles. The product is distributed by Usher-Smith Laboratories, LLC, and carries the NDC 0832-1560-11. The recall was initiated due to CGMP deviations involving intermittent exposure to temperature excursions during storage.

The affected product was distributed to Florida, Georgia, and South Carolina. The specific lot code for the recalled items is 2007346C.

Consumers and healthcare providers should check their inventory for this specific lot code and stop using the product if it matches the description. They should contact their pharmacist or healthcare provider for further instructions on how to dispose of or return the medication.

The recalled product

Product
HALOPERIDOL (HALOPERIDOL)
Brand
HALOPERIDOL
Affected units
35

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)

  • 2007346C

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 →