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RECALL RECORD — CLASS IIRecall closedF-0584-2025/FDA enforcement
Health and Happiness (H&h) LLC.·Dietary Supplements·Jan 17, 2025

Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets…

What you need to know

Class II

  • What happened

    Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. A safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

  • Action required

    Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure.

Recall closed · classified by the FDAIN, IL, TN, CAMore supplements

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Product identification

Source: FDA FOOD

Brand nameHealth and Happiness (H&h) LLC.
Recalling firmHealth and Happiness (H&h) LLC.Orlando, FL, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • EXP: JUL/2025 Lot : 2413352PSF
Distribution area
INILTNCA

Distributed in the US: IL, TN, CA

United States

Quantity affected125, 000 free samples (total)
Recall initiationFDA report date: March 12, 2025
FDA recall numberF-0584-2025

Beyond the headline

The recall, in context

Health and Happiness (H&h) LLC. initiated this supplements recall on January 17, 2025. The FDA enforcement report states: Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children. The FDA report lists distribution as: Distributed in the US: IL, TN, CA.

The FDA enforcement report describes the reason as: Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children

Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets… was made or distributed by Health and Happiness (H&h) LLC. in Orlando, FL, United States. This page reflects FDA report F-0584-2025, dated March 12, 2025.

Why this is a Class II recall

Class II means the product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. In this recall, a safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

FDA definition

The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote.

What to do now

  1. 1

    Stop using it

    Do not eat, drink or take the affected product.

  2. 2

    Check the codes

    Compare the lot and date codes against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Product safety recall

Symptoms to watch for

The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.

Higher-risk groups

Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.

What to do now

  1. 1Stop using or eating the product and keep it away from children and pets.
  2. 2Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return.
  3. 3Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Read the official source record for the specific hazard and instructions.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets… recall?

Health and Happiness (H&h) LLC. recalled Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets… in an FDA Class II enforcement action reported as F-0584-2025. Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children

What should I do if I bought this product?

Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure. Stop using or eating the product and keep it away from children and pets. Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return. Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Is the Health and Happiness (H&h) LLC. recall still active?

The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record F-0584-2025. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

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Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.