CLASS II Food recall · Reported 18 Oct 2023 · FDA Enforcement Report

Evivo with MCT Oil Infant Probiotic Activated B. infantis recalled

Infinant Health is recalling Evivo with MCT Oil Infant Probiotic Activated B. infantis EVC001 (ActiBif) For Enteral or, distributed in 13 states. The recall was initiated on 27 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number BES8042-11 BES8052-11 BES8062-11 BES8072-11 BES8082-11 BES8092-11 BES8013-11 BES8023-11 BES8033-11

Quantity recalled3,257 cartons

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

Recall details

Recall number: F-0299-2024
FDA event ID: 93136
Recalling firm: Infinant Health, Davis, CA
Brand: Evivo
Classification: Class II
Status: Terminated
Recall initiated: 27 Sep 2023
FDA classified: 24 Oct 2023
Reported: 18 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Product category: Probiotics

Timeline

27 Sep 2023	Recall initiated by company
18 Oct 2023	Published in enforcement report	+21 days
24 Oct 2023	Classified by FDA	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Unapproved food additive.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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]

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.

Alabama Arkansas California Florida Hawaii Illinois Minnesota New Jersey Nevada New York Oregon Texas Washington

Questions about this recall

Why was it recalled?

Unapproved food additive.

Which lots are affected?

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

Where was it 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.

What should I do if I have it?

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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