Food recall

Threshold Enterprises Ltd recall: Planetary Herbals Mullein Lung Complex

Threshold Enterprises Ltd, of Scotts Valley, CA, recalled Planetary Herbals Mullein Lung Complex. The FDA's reason: “Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on December 7, 2018, and the FDA first listed it in its Enforcement Report of March 6, 2019. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed June 7, 2019

The recall

Company
Threshold Enterprises Ltd (Scotts Valley, CA)
Reason, in FDA's words
“Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).”
Where it was sold
Nationwide distribution
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
82088

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-1097-2019 Class II

    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

    Codes: 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

    Quantity: 16, 542 units

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of March 6, 2019.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.