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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Food
Food & Beverages/Baby Food & Formula

Evivo with MCT Oil Infant Probiotic Recalled for Unapproved Food Additive

Agency Publication Date: October 6, 2023
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Summary

Infinant Health, LLC is recalling 3,257 cartons of Evivo with MCT Oil Infant Probiotic because it contains a food additive that has not been approved for use in this product. This infant probiotic, which contains Activated B. infantis EVC001, is intended for oral or enteral administration to help restore the gut microbiome in infants under medical supervision. No injuries or illnesses have been reported in connection with this product to date.

Risk

The recall was initiated because the product formulation includes an unapproved food additive, which does not meet federal safety standards for use in infant probiotics. Consuming unapproved additives may pose unknown health risks to infants, a vulnerable population.

What You Should Do

  1. This recall affects Evivo with MCT Oil Infant Probiotic (Activated B. infantis EVC001/ActiBif) intended for enteral or oral administration to infants.
  2. Check your product packaging for the following lot numbers: BES8042-11, BES8052-11, BES8062-11, BES8072-11, BES8082-11, BES8092-11, BES8013-11, BES8023-11, or BES8033-11.
  3. Stop using the recalled probiotic immediately.
  4. Return the product to the place of purchase for a refund, throw it away, or contact Infinant Health at customerservice@evivo.com for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Return the product to the place of purchase for a full refund, or contact the manufacturer or supplier for further instructions
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away.

Affected Products

Product: Evivo with MCT Oil Infant Probiotic
Variants: Activated B. infantis EVC001 (ActiBif), 8 Billion CFU per 0.5 milliliters
Lot Numbers:
BES8042-11
BES8052-11
BES8062-11
BES8072-11
BES8082-11
BES8092-11
BES8013-11
BES8023-11
BES8033-11

Intended for Enteral or Oral Administration. Recommended use: Thaw before use; feed 0.5 milliliters a day. For use under medical supervision.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93136
Status: Resolved
Manufacturer: Infinant Health, LLC
Sold By: Infinant Health
Manufactured In: United States
Units Affected: 3,257 cartons
Distributed To: Texas, Oregon, Washington, Arkansas, Alabama, New Jersey, Illinois, California, Florida, Minnesota, Hawaii, New York, Nevada
Agency Last Updated: October 24, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.