The Recall Desk
HighFDA (Food)·F-0859-2019·Announced 2019-02-20

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.

What this means for you

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
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.

See all 2 products in this recall →