CLASS II Food recall · Reported 6 Mar 2019 · FDA Enforcement Report
Planetary Herbals Mullein Lung Complex recalled by Threshold Enterprises
Threshold Enterprises is recalling Planetary Herbals Mullein Lung Complex, distributed nationwide in the US. The recall was initiated on 7 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-1097-2019
- FDA event ID
- 82088
- Recalling firm
- Threshold Enterprises, Scotts Valley, CA
- Brand
- Planetary Herbals
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Dec 2018
- FDA classified
- 26 Feb 2019
- Reported
- 6 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Product category
- Herbal Supplements
Timeline
| 7 Dec 2018 | Recall initiated by company | |
| 26 Feb 2019 | Classified by FDA | +81 days |
| 6 Mar 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).
Product as listed by the FDA
Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count, item number PF0003; 90 count - Item number PF0002; 180 count, Item number PF0106 and 90 + 90 count, PF 7013 white plastic bottles. Proprietary Blend: Platycodon root, Ophiopagon Rhizome, Long Pepper Fruit, Black Cherry Bark, Cassia Bark, Elecampane Root, Mullein Leaf, Licorice Root and Ginger Rhizome Extract. Manufactured for: Planetary Herbals LLC. P.O. Box 1760, Soquel, CA 95073
Where it was distributed
Nationwide distribution
Questions about this recall
Is Planetary Herbals Mullein Lung Complex recalled?
Yes. Threshold Enterprises recalled Planetary Herbals Mullein Lung Complex on 7 Dec 2018. The recall is Class II and its status is Terminated. Recall number F-1097-2019.
Why was it recalled?
Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).
Which lots are affected?
15 count lot number and expiry dates: FG-85657 - 1/21 FG-90863 - 11/21 FG-94415 - 4/22 FG-96010 - 7/22 90 count: FG-84056 - 1/21 FG-90862 - 11/21 FG-94413 - 4/22 FG-96008 - 7/22 180 count: FG-84057 - 1/21 FG-87851 - 1/21 FG-90864 - 11/21 FG-94414 - 4/22 FG-96009 - 7/22 90 + 90 Count: FG-90865 - 11/21 FG-96011 - 7/22
Where was it sold?
Nationwide distribution
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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