Infant probiotic product recall: unapproved food additive
Infinant Health is recalling Evivo infant probiotic products for containing an unapproved food additive. The recall affects 3,257 cartons distributed across 13 US states.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The recall addresses a regulatory compliance issue regarding an unapproved food additive, without documented safety incidents.
Plain-English summary
Infinant Health, LLC is recalling Evivo with MCT Oil infant probiotic products due to an unapproved food additive.
The recalled product is Evivo with MCT Oil Infant Probiotic Activated B. infantis EVC001 (ActiBif), which is intended for enteral or oral administration. The product contains Bifidobacterium longum subsp. infantis and medium chain triglyceride (MCT) oil.
The recall affects 3,257 cartons distributed to consumers in Texas, Oregon, Washington, Arkansas, Alabama, New Jersey, Illinois, California, Florida, Minnesota, Hawaii, New York, and Nevada. The affected lot numbers are BES8042-11, BES8052-11, BES8062-11, BES8072-11, BES8082-11, BES8092-11, BES8013-11, BES8023-11, and BES8033-11.
Consumers with questions about this product may contact Infinant Health at [email protected].
The recalled product
- Product
- Evivo with MCT Oil Infant Probiotic Activated B. infantis EVC001 (ActiBif) For Enteral or Oral Administration Recommended Use: Thaw before use. Feed 0.5 milliliters a day to restore the infant gut microbiome. For sure under medical supervision. Ingredients: Medium chain…
- Manufacturer
- Infinant Health, LLC
- Hazard
- Affected units
- 3,257
Distribution
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