MODERATE RISK Terminated F-0584-2025

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

Recalled by Health and Happiness (H&H) LLC.

Classification

Class II — Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.

Reason for Recall

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

Product Details

Product Quantity
125,000 free samples (total)
Product Type
Food
Code Info
EXP: JUL/2025 Lot : 2413352PSF
Voluntary/Mandated
Voluntary: Firm initiated

Distribution & Geography

Distribution Pattern
Distributed in the US: IL, TN, CA
Company Location
Orlando, FL, 32826-3018

Timeline

Report Date
03/12/2025
Recall Initiated
01/17/2025
Classification Date
02/28/2025
Termination Date
04/02/2025

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: August 28, 2026

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