Basic Reset Recalls Ionyte Dietary Supplement for CGMP Violations
Basic Reset Inc. is recalling Ionyte 4 fl. oz. bottles because the products do not conform to Dietary Supplement CGMP regulations.
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, but the source text does not report any illnesses, injuries, or specific high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Basic Reset Inc. is voluntarily recalling Ionyte 4 fl. oz. plastic bottles (SKU: 100-1B) because the products do not conform to Dietary Supplement Current Good Manufacturing Practice (CGMP) regulations. The recall is classified as Class II by the U.S. Food and Drug Administration.
The affected product was shipped to all 50 states and to foreign consignees in Canada, Nigeria, the U.K., Australia, Israel, Puerto Rico, the Virgin Islands, Hungary, the UAE, Mexico, the Philippines, and Greece. Specific lot codes associated with the recall include 29049, 28343, 27618A, 19018B, 35317B, 101617, 08518A, and 29123.
Consumers who have purchased this product should check their inventory for the listed SKU and lot codes. If the product matches the description, consumers should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Ionyte 4 fl. oz. plastic bottle, SKU: 100-1B
- Manufacturer
- Basic Reset Inc.
- Category
- Food — 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 (8)
- 29049
- 28343
- 27618A
- 19018B
- 35317B
- 101617
- 08518A
- 29123
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 14 recalled by Basic Reset 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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