Class IITerminated · reported 2023-10-18

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

Infinant Health, LLC recalled this product and the FDA reported the enforcement action on 18 October 2023 as Class II. The recall was initiated by the firm. Unapproved food additive.

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

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 customerservice@evivo.com
Reason for recall: Unapproved food additive.
Recalling firm: Infinant Health, LLC
Firm location: Davis, California, United States
Classification: Class II
Status: Terminated
Recall number: F-0299-2024
Quantity: 3,257 cartons
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.
Initiated: 27 September 2023
Reported by FDA: 18 October 2023
Terminated: 10 September 2024
Firm notified by: Letter
Product codes: Lot Number BES8042-11 BES8052-11 BES8062-11 BES8072-11 BES8082-11 BES8092-11 BES8013-11 BES8023-11 BES8033-11

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
This record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 11 months, from 27 September 2023 to termination on 10 September 2024. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
The distribution pattern names 12 states, and the FDA published the enforcement report 3 weeks after the firm began the recall.
Recalls of infant formula or baby food run a median of 10 months, so this one was about typical for its category. Infant formula is the most tightly regulated food in the United States because it is frequently the only thing an infant eats, so a nutrient deviation is a hazard in a way it is not in any other product.

Named in the distribution pattern: Oregon, Washington, Arkansas, Alabama, New Jersey, Illinois, California, Florida, Minnesota, Hawaii, New York, Nevada. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

What this recall was for

Unapproved ingredients

An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.

A preventive controls plan covers an unapproved ingredient under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.

21 CFR 111: Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.
21 CFR 117 subpart G: Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.

Filed under infant formula and baby food, milk and dairy and dietary supplements. A product can sit in more than one.

All 2023 recalls · All FDA food recall data

21 CFR 111 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.