Mylan Recalls DrNatura Flora Protect Probiotics Due to Undeclared Soy Allergen
Mylan Pharmaceuticals is recalling DrNatura Flora Protect Probiotics because the product contains an undeclared soy allergen.
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 Pharmaceuticals Inc. is recalling 2,378 bottles of DrNatura Flora Protect Probiotics, Item# 46017-088-04, Lot 3020068. The product has an expiration date of March 2019 and was distributed in the US market.
The recall was initiated because the product contains an undeclared soy allergen. This labeling error poses a risk to consumers with soy allergies.
Consumers with this specific lot number should stop using the product and contact the manufacturer for instructions on disposal or return.
The recalled product
- Product
- DrNatura Flora Protect¿ Probiotics
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Food — Probiotics
- Hazard
- Affected units
- 2,378
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 3020068 Item# 46017-088-04
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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