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.
What this means for you
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
- Hazard
- unapproved-claims
- misbranding
- labeling
Distribution
Distributed in 12 states:
- AL
- AZ
- CA
- GA
- IL
- IN
- MN
- MO
- MS
- NC
- NY
- TN
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