Mylan Recalls DrNatura Probiotics and Detox Kits for Undeclared Soy
Mylan Pharmaceuticals is recalling DrNatura Flora Protect Probiotics and Toxinout Kits due to an undeclared soy allergen statement.
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: The recall involves allergen mislabeling on a common allergen (soy), which corresponds to a severity score of 3 (High) according to the rubric.
Plain-English summary
Mylan Consumer Healthcare has initiated a recall of two specific DrNatura products: Flora Protect Probiotics (Item# 46017-088-04, Lot 3020068, Expiry Mar 2019) and Toxinout Kit (Item# 46017-088-18, Lot 005983-001, Expiry Dec 2018). The recall is being conducted because the products contain an undeclared soy allergen.
The affected products were distributed in the US market. The recall involves 800 kits of the Toxinout Kit. The FDA has classified this recall as Class II.
Consumers with these specific products should stop using them and contact Mylan Pharmaceuticals for further instructions or a refund. Individuals with a soy allergy should be particularly cautious and avoid using these products.
The recalled product
- Product
- DrNatura Toxinout Kit Broad Spectrum Detoxification Program
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Food — Dietary Supplements
- Hazard
- Affected units
- 800
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)
- Lot 005983-001 Item# 46017-088-18
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Mylan Pharmaceuticals Inc. 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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