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

Recall Insight

This FDA Food action (record #F-0584-2025) was formally reported on March 12, 2025, with the manufacturer initiating the action on January 17, 2025. It is classified under Moderate severity (Class II), with a current status of Terminated. Health and Happiness (H&h) LLC. is listed as the recalling firm, operating out of Orlando, FL. Federal records indicate 125,000 free samples (total) units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children Distribution data in the federal record shows the product reached: Distributed in the US: IL, TN, CA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Food. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.