Class IITerminated in FDA datasetRecall initiated Sep 27, 2023

Evivo with MCT Oil Infant Probiotic Activated B. infantis EVC001 (ActiBif) For Enteral or Oral…

Recalling firm: Infinant Health, LLC

Why it was recalled

Unapproved food additive.

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Sep 10, 2024.

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ProductEvivo 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

FDA code information

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

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Full FDA record and distribution details

Original product description

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

Original FDA recall reason

Unapproved food additive.

Recall details

Recall number
F-0299-2024
Event ID
93136
FDA status
Terminated
Initiated
Sep 27, 2023
Reported
Oct 18, 2023
Classified
Oct 24, 2023
Terminated
Sep 10, 2024
Quantity
3,257 cartons
Location
Davis, CA, United States
Initiation type
Voluntary: Firm initiated
Notification
Letter

Where it was distributed

U.S. Distribution to the following: TX, OR, WA, AR, AL, NJ, IL, CA, FL, MN, HI, NY, NV, and AR No foreign distribution.

FDA source record · F-0299-2024

Data updated September 16, 2026. View official FDA data ↗

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