Livia One Organic Probiotic Nasal Spray Recalled for Pseudomonas Contamination
Livia Global is recalling Livia One Organic Probiotic Nasal Spray due to contamination with Pseudomonas aeruginosa, a bacterium that can cause respiratory infection.
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: Pseudomonas aeruginosa is a high-risk pathogen capable of causing serious respiratory infections, particularly when inhaled via nasal spray. The FDA classification of Class II and the absence of reported illnesses place this at the High severity level per the rubric.
Plain-English summary
Livia Global Inc. is recalling Livia One Organic Probiotic Nasal Spray, 1 oz. (30 ml) bottles, UPC 0 30915 10719 8, because the product has been found to be contaminated with Pseudomonas aeruginosa.
The affected product includes Lot #001005-1 (best-by date 04/2023) and Lot #010620-1 (best-by date 08/2023). A total of 1,130 bottles were distributed by Livia Global Inc., Visalia, CA.
Consumers who have purchased this product should stop use immediately. The product was marketed for use by adults and children ages 4 and older. Anyone who has used the product and has concerns about their health should consult a healthcare provider.
The recalled product
- Product
- Livia One Organic Probiotic Nasal Spray; 1 oz. (30 ml) UPC: 0 30915 10719 8 Suggested use: Adult - 102 pumps in each nostril as needed 1-3 times per day; Children 4-12 years : 1/4-1/2 pump in each nostril as needed - 103 times daily as needed. Children 3 and under: It…
- Manufacturer
- Livia Global
- Category
- Drug — Nasal Spray / Probiotic
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 (4)
- Lot #001005-1
- BB 04/2023
- Lot # 010620-1
- BB 08/2023
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Livia Global under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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