Severity
Moderate
ModerateClass IITerminated
FDA Food recall · Reported March 6, 2019
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
Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).
Compiled from official public sources by the editorial team.
Verify with FDA Food →
Threshold Enterprises Ltd recalled Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count, item number PF0003; 90 count … - a moderate-severity action.
Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count, item number PF0003; 90 count … was recalled by Threshold Enterprises Ltd in March 6, 2019. Reason: Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inac…. Check the official notice for the remedy. Verify recall #F-1097-2019 with the FDA Food before acting.
The recall
Threshold Enterprises Ltd issued this moderate-severity FDA Food recall-Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inac….
- Moderate
- severity level
- Class II
- classification
- March 6, 2019
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-1097-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-1097-2019) was formally reported on March 6, 2019, with the manufacturer initiating the action on December 7, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Threshold Enterprises Ltd is listed as the recalling firm, operating out of Scotts Valley, CA. Federal records list the affected scope as 16, 542 units.
The documented reason for this recall is: Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients). Distribution data in the federal record shows the product reached: Nationwide distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 2 from FDA Food - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Food recalls over time
Where this recall sits in its category - 25,126 food recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
16, 542 units
Related Recalls
6
2 from same agency
Product description
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
Reason for recall
Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | F-1097-2019 |
| Date reported | March 6, 2019 |
| Date initiated | December 7, 2018 |
| Recalling firm | Threshold Enterprises Ltd |
| Firm location | Scotts Valley, CA |
| Affected scope | 16, 542 units |
| Distribution | Nationwide distribution |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-1097-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Threshold Enterprises Ltd. Units affected: 16, 542 units.
Why was this product recalled? ▼
Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).
Which agency issued this recall? ▼
This recall was issued by the FDA Food on March 6, 2019. Severity: Moderate. Recall number: F-1097-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-1097-2019) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported March 6, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.