Sinus Cap herbal capsules recalled over unapproved drug claims and misbranding
A New Life Herbs is recalling 38 bags of Sinus Cap Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.
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: Scored 2 under the minor labeling criterion: the record cites unapproved claims and a missing Supplement Facts panel, with no stated illness or defect.
Plain-English summary
Sinus Cap Herbal Supplement, described on the label as containing herbs with antibiotic, drying, expectorant and emollient properties, comprising fenugreek, thyme, Oregon grape root and bentonite clay, supplied as 50 capsules of 510 mg in a plastic bag is being recalled by A New Life Herbs, LLC.
The reason given in the enforcement record is unapproved drug claims on the product labeling, and that the product is misbranded due to having no Supplement Facts label.
The recall covers 38 bags, codes including C136SC, C128SC, C110SC, C109SC and C102SC with expiries listed in the enforcement record. Distribution covered Alabama, Arizona, California, Georgia, Illinois, Indiana, Minnesota, Missouri, Mississippi, North Carolina, New York and Tennessee. The FDA has classified the action as Class II.
The record cites labeling and misbranding issues rather than a contamination or defect, and states no illnesses. Consumers should follow the firm's instructions.
The recalled product
- Product
- Sinus Cap Herbal Supplement, Herbs containing antibiotic, drying, expectorant, and emollient properties, Fenugreek, Thyme, Oregon Grape Root, & Bentonite Clay, 50 capsules/510 mg; packaged in a plastic bag
- Manufacturer
- A New Life Herbs, LLC
- Category
- Food — Herbal supplement
- Affected units
- 38
Distribution
Part of a larger recall action
This product is one of 9 recalled by A New Life Herbs, LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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