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Food FDA Class II Terminated Foreign material

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

Health and Happiness (H&H) LLC. Published Mar 12, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 45/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Health and Happiness (H&H) LLC. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Metal · primary

Affected products (1)

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

125,000 free samples (total)

Lot codes: 2413352PSF
Code info: EXP: JUL/2025 Lot : 2413352PSF

Affected areas

CaliforniaIllinoisTennessee

Timeline

  1. Initiated
    Jan 17, 2025
  2. Published
    Mar 12, 2025
  3. Terminated
    Apr 2, 2025
Recall number
F-0584-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA food enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.