Dietary Supplement Recalled for Undeclared New Ingredient
Bio-Botanica is recalling NATURE's ANSWER Coral Calcium supplements because the product contained cesium chloride, a New Dietary Ingredient. The recall affects 6852 bottles distributed to 17 states.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory in nature—an undeclared New Dietary Ingredient—rather than a demonstrated acute contamination or safety incident. Per the rubric, Class II recalls without hospitalization reports and involving labeling or regulatory violations are scored as Moderate.
Plain-English summary
NATURE's ANSWER Coral Calcium dietary supplement, manufactured by Bio-Botanica, Inc., is being recalled because it contains cesium chloride, classified as a New Dietary Ingredient.
The recall affects 6852 bottles of the 90-capsule product with four specific lot numbers: Lot 203279 (September 2020), Lot 194079 (December 2019), Lot 190719 (April 2019), and Lot 183383 (September 2018). These bottles were distributed to retailers in Rhode Island, Florida, Indiana, Oklahoma, Wisconsin, Texas, Michigan, California, Missouri, Pennsylvania, Tennessee, New York, Arizona, Delaware, Virginia, Connecticut, and Ohio.
Consumers who have purchased NATURE's ANSWER Coral Calcium with any of these lot numbers should discontinue use. Consult with a healthcare provider if you have any questions or concerns about your use of this product.
The recalled product
- Product
- NATURE's ANSWER Coral Calcium; Antioxidant Benefits*; 1000mg Coral Calcium per serving; DIETARY SUPPLEMENT; 90 capsules
- Manufacturer
- Bio-Botanica, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 6,852
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)
- Lot 203279 - 9/2020
- Lot 194079 - 12/2019
- Lot 190719-4/2019
- Lot 183383 - 9/2018
Distribution
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