Peaceful Mountain Nasal Rescue Recalled as Unapproved New Drug
Grato Holdings is recalling Peaceful Mountain Nasal Rescue dietary supplements because they are unapproved new drugs based on disease claims.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the hazard is regulatory (unapproved new drug) rather than a specific acute physical hazard like a pathogen or allergen.
Plain-English summary
Grato Holdings, Inc. is recalling Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support. The product is distributed by Peaceful Mountain, Inc. in Woodbine, Iowa.
The recall is being conducted because the product is an unapproved new drug based on disease claims or routes of administration. The source text does not report any illnesses or injuries associated with this recall.
Approximately 27,860 1.5 oz bottles were shipped to customers nationwide and in Canada. Affected products may bear the codes G9558, G9716, G10110, or G10471. Consumers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
- Manufacturer
- Grato Holdings, Inc.
- Category
- Drug — Dietary Supplement
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- G9558
- G9716
- G10110
- G10471
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Grato Holdings, Inc. 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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