Class IITerminated in FDA datasetJan 17, 2025

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

Recalling firm: Health and Happiness (H&H) LLC.

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

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The exact product

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

Check the codes

Compare these FDA-provided codes, lot numbers or dates with the product you have.

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Original FDA code information

EXP: JUL/2025 Lot : 2413352PSF

TypeCode / valueContext
lot2413352PSFEXP: JUL/2025 Lot : 2413352PSF
lot2413352PSF Flexible Sachet packaging, Sample size package (4 Count), EXP: JUL/2025 Lot : 2413352PSF

Recall details

Recall number
F-0584-2025
Event ID
96225
FDA status
Terminated
Initiated
Jan 17, 2025
Reported
Mar 12, 2025
Classified
Feb 28, 2025
Terminated
Apr 2, 2025
Quantity
125,000 free samples (total)
Location
Orlando, FL, United States
Initiation type
Voluntary: Firm initiated
Notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Where it was distributed

Distributed in the US: IL, TN, CA

FDA source record · F-0584-2025

Data updated September 16, 2026. View official FDA data ↗

A missing code match is not a guarantee of safety. Follow official FDA and manufacturer guidance.