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FDA recall record

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 res...

Recall F-0299-2024Class IITerminatedSeptember 27, 2023

FDA classification. FDA Class I, II, and III are not the same as USDA FSIS classifications and are not a cross-agency safety score.

FDA listed a termination date of September 10, 2024. openFDA does not treat this as a live recall-status tracker.

Product described in an FDA recall

Evivo with MCT Oil Infant Probiotic Activated B. infantis EVC001 (ActiBif) For Enteral or Oral Administration Recommended Use: Thaw before use. 5 milliliters a day to restore the infant gut microbiome. For sure under medical supervision. Ingredients: Medium chain triglucerides (MCT) oil, Bifidobacterium longum subsp. com

Reason

Unapproved food additive.

Products involved

Product descriptions are copied from the FDA recall record. They are not a current catalog and are not automatically matched to WhoMadeMyFood product pages.

  • Evivo with MCT Oil Infant Probiotic Activated B. infantis EVC001 (ActiBif) For Enteral or Oral Administration Recommended Use: Thaw before use. 5 milliliters a day to restore the infant gut microbiome. For sure under medical supervision. Ingredients: Medium chain triglucerides (MCT) oil, Bifidobacterium longum subsp. com

Code information listed by FDA

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

Distribution and firm information

Recalling firm listed by FDA: Infinant Health, LLC

Firm location listed by FDA: Davis, CA, United States

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

Product quantity listed by FDA: 3,257 cartons

Source

Source: U.S. Food and Drug Administration (FDA), openFDA food enforcement reports.

Official FDA openFDA food enforcement record

Identifying an FDA recall record does not imply FDA endorsement of WhoMadeMyFood. Methodology.