Planetary Herbals Mullein Lung Complex Recalled for Labeling Error
Planetary Herbals is recalling Mullein Lung Complex capsules due to a labeling error regarding inactive ingredients.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding inactive ingredients, which fits the rubric for moderate severity.
Plain-English summary
Planetary Herbals LLC is recalling specific lots of Mullein Lung Complex capsules because of a labeling error. The product labels incorrectly list the excipient profile, which refers to the inactive ingredients in the supplement.
The recall affects 16,542 units of the product in 15, 90, 180, and 90+90 count white plastic bottles. The affected lots were distributed nationwide. The product is manufactured by Threshold Enterprises Ltd for Planetary Herbals LLC.
Consumers should check their bottles for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, consumers should stop using it and follow the instructions provided by the company or the FDA for disposal or return.
The recalled product
- Product
- 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…
- Manufacturer
- Threshold Enterprises Ltd
- Category
- Food — Dietary Supplement
- Hazard
Distribution
Distributed nationwide across the United States.
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