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

Lot, batch or date codes15 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
Quantity recalled16, 542 units

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
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 2018Recall initiated by company
26 Feb 2019Classified by FDA+81 days
6 Mar 2019Published 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

Nationwide

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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