Recall · openFDA Food Enforcement

Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and…: FDA Recall F-0584-2025

Agency action: Jan 17, 2025Record ID: F-0584-2025
View official source ↗

What happened

Original notice title

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 :…

From the archived source record

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

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

Read the official notice →

Status and source details

Status recorded in the archive
Terminated
FDA recall classification
Class II
Recall initiated by
Voluntary: Firm initiated
Report date
Mar 12, 2025
Termination date in the archive
Apr 2, 2025
Source checked
Jul 16, 2026
Record revision
649bb6655058

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

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
Company
Health and Happiness (H&H) LLC.
Lot / identifier
EXP: JUL/2025 Lot : 2413352PSF
Market / distribution
Distributed in the US: IL, TN, CA