What is the FDA's Class II risk classification for the olive oil recall?

A Class II classification means the use of the product may cause temporary adverse health effects or the probability of serious health consequences is remote.

Which olive oil products are being recalled by Hale Inc.?

Two specific infused olive oil products manufactured by Hale Inc. are subject to the recall due to potential botulism contamination.

Where were the recalled olive oil products distributed?

The affected olive oil products were distributed exclusively within the state of Kentucky.

Home / Health / Botulism Scare: Olive Oil Recall Issued

Botulism Scare: Olive Oil Recall Issued

9 Dec, 2025

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Summary

Two infused olive oil products were recalled due to botulism contamination risk.
The recall was issued a Class II risk classification by the U.S. FDA.
Affected products were distributed exclusively within Kentucky.

Hale Inc. initiated a voluntary recall for two infused olive oil products on September 9, 2025, following concerns over their manufacturing process lacking FDA approval. The U.S. Food and Drug Administration (FDA) later classified this recall as Class II on December 8, 2025, indicating a potential for temporary or medically reversible health consequences.

The recall specifically targets products distributed within Kentucky. Botulism, caused by the bacterium Clostridium botulinum, can produce a dangerous toxin that attacks the nervous system, potentially leading to severe health issues including paralysis and death.