The Recall Desk
Agency classClass IIOur severity:HighFDA (Food)·F-0584-2025·Announced 2025-03-12

Biostime Kids Calm & Sleep Support Gummies Recalled for Metal Ball Contamination

Health and Happiness LLC is recalling Biostime Kids Calm & Sleep Support Fruity Bites gummies due to tiny non-magnetic metal balls inside the product. The affected lot poses a choking hazard to children.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II FDA recall for foreign object contamination (metal balls) in a children's product. This is a risk-of-harm product where potential choking injury has not yet been reported, meeting the High severity criterion.

Plain-English summary

Health and Happiness LLC is recalling Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets (gummy supplements) due to the presence of tiny non-magnetic metal balls, measuring less than 2mm, found inside the gummies.

The recalled product is a sample-size package containing 4 sachets with an expiration date of July 2025 and lot number 2413352PSF. A total of 125,000 free samples were distributed in the United States across Illinois, Tennessee, and California.

The metal balls pose a choking hazard, particularly for children who are the intended consumers of this product. No illnesses or injuries have been reported to date.

Consumers who have received this product should stop use immediately and discard the product. For questions, contact Health and Happiness LLC.

The recalled product

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
Manufacturer
Health and Happiness (H&H) LLC.
Category
Food — Dietary Supplement / Gummy
Hazard
Affected units
125,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • EXP: JUL/2025 Lot : 2413352PSF

Distribution

Distributed in 3 states:

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