Evivo with MCT Oil Infant Probiotic Activated B. infantis EVC001 (ActiBif) For Enteral or Oral Administration Recomme... — FDA record F-0299-2024

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 27, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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 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 [email protected]
Reason
Unapproved food additive.
Classification
Class II
Recalling firm
Infinant Health, LLC
Quantity
3,257 cartons
Agency-reported status
Terminated
Source record identifier
F-0299-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot Number BES8042-11 BES8052-11 BES8062-11 BES8072-11 BES8082-11 BES8092-11 BES8013-11 BES8023-11 BES8033-11

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Oct 18, 2023
Recall initiation date
Sep 27, 2023
Center classification date
Oct 24, 2023
Termination date
Sep 10, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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