Food recall

Infinant Health, LLC recall: Evivo with MCT Oil Infant Probiotic Activated B

Infinant Health, LLC, of Davis, CA, recalled Evivo with MCT Oil Infant Probiotic Activated B. The FDA's reason: “Unapproved food additive.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on September 27, 2023, and the FDA first listed it in its Enforcement Report of October 18, 2023. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed September 10, 2024

The recall

Company
Infinant Health, LLC (Davis, CA)
Reason, in FDA's words
“Unapproved food additive.”
Where it was sold
U.S. Distribution to the following: TX, OR, WA, AR, AL, NJ, IL, CA, FL, MN, HI, NY, NV, and AR No foreign distribution.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
93136

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-0299-2024 Class II

    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 triglucerides (MCT) oil, Bifidobacterium longum subsp. infantins EVC001 (milk, soy) CFU Count: 8 Billion CFU per 0.5 milliliters Manufactured For: Infinant Health Davis, CA 95618 customerservice@evivo.com

    Codes: Lot Number BES8042-11 BES8052-11 BES8062-11 BES8072-11 BES8082-11 BES8092-11 BES8013-11 BES8023-11 BES8033-11

    Quantity: 3,257 cartons

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of October 18, 2023.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.