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Class II: temporary or reversible health riskTerminated

Health and Happiness (H&H) Biostime Kids Calm & Sleep Support Fruity Recall

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

Health and Happiness (H&H) LLC. · Orlando, FL

Risk level
Class II
Reported by FDA
Mar 12, 2025
Recall ID
F-0584-2025
Check your lot numberHow we source this data

Summary

Health and Happiness (H&H) recalled Biostime Kids Calm & Sleep Support Fruity starting Jan 17, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-0584-2025 on Mar 12, 2025. Reason: Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

EXP: JUL/2025 Lot : 2413352PSF

Where it was sold

Distributed in the US: IL, TN, CA

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-0584-2025
Classification
Class II
Status
Terminated
Recall initiated
Jan 17, 2025
FDA report date
Mar 12, 2025
Quantity
125,000 free samples (total)
Recall type
Voluntary: Firm initiated
Recalling firm
Health and Happiness (H&H) LLC.

Original FDA data

Every field from FDA enforcement report F-0584-2025, exactly as published.

Show all FDA fields
City
Orlando
State
FL
Status
Terminated
Country
United States
Event ID
96225
Address
13501 Ingenuity Dr Ste 150
Code information
EXP: JUL/2025 Lot : 2413352PSF
Postal code
32826-3018
Report date
Mar 12, 2025
Product type
Food
Recall number
F-0584-2025
Classification
Class II
Recalling firm
Health and Happiness (H&H) LLC.
Product quantity
125,000 free samples (total)
Termination date
Apr 2, 2025
Reason for recall
Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Distributed in the US: IL, TN, CA
Recall initiation date
Jan 17, 2025
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Feb 28, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0584-2025, published Mar 12, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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