Severity
Moderate
ModerateClass IITerminated
FDA Food recall · Reported March 12, 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
Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children
Health and Happiness (H&h) LLC. recalled Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets (… - a moderate-severity action.
Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets (… was recalled by Health and Happiness (H&h) LLC. in March 12, 2025. Reason: Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies)…. Check the official notice for the remedy. Verify recall #F-0584-2025 with the FDA Food before acting.
The recall
Health and Happiness (H&h) LLC. issued this moderate-severity FDA Food recall-Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies)….
- Moderate
- severity level
- Class II
- classification
- March 12, 2025
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-0584-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
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 list the affected scope as 125,000 free samples (total).
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.
Within the same product category the archive holds 6 closely related recalls, 2 from FDA Food - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Food recalls over time
Where this recall sits in its category - 25,126 food recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
125,000 free samples (total)
Related Recalls
6
2 from same agency
Product description
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
Reason for recall
Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | F-0584-2025 |
| Date reported | March 12, 2025 |
| Date initiated | January 17, 2025 |
| Recalling firm | Health and Happiness (H&h) LLC. |
| Firm location | Orlando, FL |
| Affected scope | 125,000 free samples (total) |
| Distribution | Distributed in the US: IL, TN, CA |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-0584-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Units affected: 125,000 free samples (total).
Why was this product recalled? ▼
Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children
Which agency issued this recall? ▼
This recall was issued by the FDA Food on March 12, 2025. Severity: Moderate. Recall number: F-0584-2025.
Where was the recalled product distributed? ▼
Distribution: Distributed in the US: IL, TN, CA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-0584-2025) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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FDA Food Critical
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Compare this recall with Conair Recalls Over One Million Cuisinart Grill Brushes Due… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported March 12, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.