CLASS II Food recall · Reported 12 Mar 2025 · FDA Enforcement Report
Biostime Kids Calm & Sleep Support Fruity Bites Probiotics recalled
Health and Happiness (H&H) is recalling Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets, distributed in California, Illinois, Tennessee. The recall was initiated on 17 Jan 2025 and the FDA has classified it as Class II.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- F-0584-2025
- FDA event ID
- 96225
- Recalling firm
- Health and Happiness (H&H), Orlando, FL
- Brand
- Biostime Kids
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jan 2025
- FDA classified
- 28 Feb 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Product category
- Probiotics
Timeline
| 17 Jan 2025 | Recall initiated by company | |
| 28 Feb 2025 | Classified by FDA | +42 days |
| 12 Mar 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Distributed in the US: IL, TN, CA
Questions about this recall
Is Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets recalled?
Yes. Health and Happiness (H&H) recalled Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets on 17 Jan 2025. The recall is Class II and its status is Terminated. Recall number F-0584-2025.
Why was it recalled?
Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children
Which lots are affected?
EXP: JUL/2025 Lot : 2413352PSF
Where was it sold?
Distributed in the US: IL, TN, CA
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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