Class IITerminatedVoluntary: Firm initiated
Health and Happiness (H&H) LLC.: food recall F-0584-2025
Health and Happiness (H&H) LLC. of Orlando, FL recalled Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets (gummies), Flexible Sachet… Reason: Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children. The FDA listed it as Class II in its Enforcement Report dated Mar 12, 2025; distribution: California, Illinois, Tennessee.
Record status as published: Terminated (terminated Apr 2, 2025). openFDA data last updated Oct 21, 2026.
Have this product? Check FDA.gov and your retailer. This page reproduces an FDA Enforcement Report record and is not a public alert. Look for the firm's recall notice on the FDA's recalls page, or ask the store where you bought it what to do. If you think you got sick from a food, contact a health care provider.
Recall details
- 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
- Product quantity
- 125,000 free samples (total)
- Reason for recall
- Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children
- Codes, lots and dates on the package
- EXP: JUL/2025 Lot : 2413352PSF
- Distribution pattern
- Distributed in the US: IL, TN, CA
- Recalling firm
- Health and Happiness (H&H) LLC., Orlando, FL
- Classification
- Class II — the FDA uses this class for a situation in which using or being exposed to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
- Voluntary or mandated
- Voluntary: Firm initiated
- How the firm first notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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Dates
| Event | Date |
|---|---|
| Recall initiated by the firm | Jan 17, 2025 |
| Classified by the FDA | Feb 28, 2025 |
| Published in the Enforcement Report | Mar 12, 2025 |
| Terminated | Apr 2, 2025 |
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Sources
- U.S. Food and Drug Administration, openFDA food enforcement reports, recall number F-0584-2025 (openFDA record). Data provided by the U.S. Food and Drug Administration (https://open.fda.gov).
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