CLASS II Food recall · Reported 20 Feb 2019 · FDA Enforcement Report
DrNatura Flora Protect¿ Probiotics recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling DrNatura Flora Protect¿ Probiotics. The recall was initiated on 10 Dec 2018 and the FDA has classified it as Class II.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- F-0858-2019
- FDA event ID
- 81774
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Brand
- DrNatura Flora
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Dec 2018
- FDA classified
- 8 Feb 2019
- Reported
- 20 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Undeclared Soy
- Product category
- Probiotics
Timeline
| 10 Dec 2018 | Recall initiated by company | |
| 8 Feb 2019 | Classified by FDA | +60 days |
| 20 Feb 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 Dr Natura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 . The products are being recalled due to undeclared soy allergen statement.
Product as listed by the FDA
DrNatura Flora Protect¿ Probiotics
Where it was distributed
US Market
Questions about this recall
Why was it recalled?
Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 Dr Natura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 . The products are being recalled due to undeclared soy allergen statement.
Which lots are affected?
Lot 3020068 Item# 46017-088-04
Where was it sold?
US Market
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 81774This product is part of a recall event; the main page for the event is DrNatura Toxinout Kit Broad Spectrum Detoxification Program recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DrNatura Toxinout Kit Broad Spectrum Detoxification Program recalledDrNatura Toxinout | Mylan Pharmaceuticals | Undeclared Soy | WV |
More recalls from Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Probiotics recalls
All 72| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | Neuro Nourish dietary supplement;-1 Prebiotic, Probiotic recalledNeuro Nourish | Sensory Supplement | Other | Nationwide |
| Food | CLASS I | SunBiotics Activated Almonds Infused with Probiotics recalledSunBiotics Activated | Windy City Organics | Salmonella | 7 states |
| Food | CLASS II | Biostime Kids Calm & Sleep Support Fruity Bites Probiotics recalledBiostime Kids | Health and Happiness (H&H) | Foreign Material | CA, IL, TN |
| Food | CLASS II | ZOE Daily 30+ Prebiotic blend recalled by Zoe USZoe | Zoe US | Foreign Material | 26 states |
| Food | CLASS I | Mt. Capra Goat Milk Formula Recipe Kit recalled by Healthwest MineralsMt. Capra | Healthwest Minerals | Packaging Defects | Nationwide |