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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