Dietary supplement Microbiome Rejuvenate recalled for glass fragment contamination
Big Bold Health is recalling Microbiome Rejuvenate dietary supplement bottles due to glass fragment contamination. The recall affects 1,087 bottles distributed nationwide and internationally.
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: FDA Class II recall with no reported hospitalizations or illnesses. Glass fragments present a physical hazard that could cause choking or internal injury if ingested, qualifying as a 'risk-of-harm product where injury has not yet been reported' per the rubric.
Plain-English summary
Microbiome Rejuvenate dietary supplement is being recalled by Big Bold Health Holdings Inc due to glass fragments found in the product. The recalled product consists of bottles containing 60 capsules each (UPC 8 50033 36201 5).
The affected lot is #10249 with expiration date 01/10/2025. A total of 1,087 bottles were distributed, reaching consumers in the United States nationwide (including Puerto Rico) and in Australia, Canada, Sweden, Switzerland, and Taiwan.
This was a voluntary recall initiated by the firm on April 27, 2023, and was terminated on December 13, 2023. The firm initially notified consumers by telephone.
The recalled product
- Product
- Microbiome Rejuvenate dietary supplement, 60 capsules per bottle, UPC: 8 50033 36201 5. Distributed by Big Bold Health, Bainbridge Island, WA.
- Manufacturer
- Big Bold Health Holdings Inc
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 1,087
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 (2)
- Lot #10249
- EXP: 01/10/2025
Distribution
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