Food, drugs, devices › Mylan Pharmaceuticals Inc.
Food recall: DrNatura Flora Protect¿ Probiotics
Mylan Pharmaceuticals Inc. (Morgantown, WV) initiated this food recall on 10 Dec 2018; FDA lists 2 product records under event 81774, classified Class II.
FDA defines Class II as 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. 56% of the 578 food enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 22 Oct 2019. Initiation: voluntary: firm initiated. Mylan Pharmaceuticals Inc. has 55 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mylan Pharmaceuticals Inc., Morgantown, WV.
Reason for recall
"Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 DrNatura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 and Item# 46017-088-18 DrNatura Toxinout Kit lot 005983-001 Expiry Dec 2018 . The products are being recalled due to undeclared soy allergen statement."
Distribution
"US Market"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-0858-2019 | DrNatura Flora Protect¿ Probiotics | 2378 Bottles | Class II | Terminated | 20 Feb 2019 |
| F-0859-2019 | DrNatura Toxinout Kit Broad Spectrum Detoxification Program | 800 Kits | Class II | Terminated | 20 Feb 2019 |
Context
Other enforcement events for Mylan Pharmaceuticals Inc.
All 55 events for Mylan Pharmaceuticals Inc.
Questions and answers
Why was this food recalled?
FDA's record gives the reason for recall as: "Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 DrNatura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 and Item# 46017-088-18 DrNatura Toxinout Kit lot 005983-001 Expiry Dec 2018 . The products are being recalled due to undeclared soy allergen statement."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Market"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Oct 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA food enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.