Food recall

Merical, LLC recall: Leader Advanced Probiotic with 6 Probiotic Strains and 20 billion Live Cultures

Merical, LLC, of Orange, CA, recalled Leader Advanced Probiotic with 6 Probiotic Strains and 20 billion Live Cultures. The FDA's reason: “Incorrect Probiotic blend indicated in the Supplemental Facts Panel on product label.” The FDA classified it Class III: it is unlikely to cause harm. The company began the recall voluntarily on October 31, 2019, and the FDA first listed it in its Enforcement Report of December 4, 2019. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class III

It is unlikely to cause harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed March 6, 2020

The recall

Company
Merical, LLC (Orange, CA)
Reason, in FDA's words
“Incorrect Probiotic blend indicated in the Supplemental Facts Panel on product label.”
Where it was sold
One customer in OH who then distributed product nationwide
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
84302

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-0193-2020 Class III

    Leader Advanced Probiotic with 6 Probiotic Strains and 20 billion Live Cultures. 30 capsules Item Number: CARD40359, Product Number: 907019, UPC Code: 096295136654

    Codes: Batch Numbers: 300-00027721 and 300-00027515, Pkg Numbers: 907727721 and 913327515, Expiration Dates: 08/2020 and 04/2021.

    Quantity: 442 cases

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of December 4, 2019.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.