Food recall

Health and Happiness (H&H) LLC. recall: Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets (gummies), Flexible Sachet...

Health and Happiness (H&H) LLC., of Orlando, FL, recalled Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets (gummies), Flexible Sachet.... The FDA's reason: “Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on January 17, 2025, and the FDA first listed it in its Enforcement Report of March 12, 2025. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Metal, plastic, glass or other objects

Status

Terminated

Closed April 2, 2025

The recall

Company
Health and Happiness (H&H) LLC. (Orlando, FL)
Reason, in FDA's words
“Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children”
Where it was sold
Distributed in the US: IL, TN, CA
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
96225

The product recalled

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

  • F-0584-2025 Class II

    Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets (gummies), Flexible Sachet packaging, Sample size package (4 Count), EXP: JUL/2025 Lot : 2413352PSF

    Codes: EXP: JUL/2025 Lot : 2413352PSF

    Quantity: 125,000 free samples (total)

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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 March 12, 2025.

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.