RegenErect Herbal Supplements Recalled for Manufacturing Violations
VivaCeuticals is recalling RegenErect herbal and dietary supplements because they were not manufactured in compliance with current Good Manufacturing Practice 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, which typically involves a remote possibility of serious adverse health consequences. The hazard is a manufacturing compliance issue (cGMP) rather than a specific contamination or mislabeling of a high-risk allergen, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
VivaCeuticals, Inc. dba Regeneca Worldwide is recalling all lots of RegenErect herbal and dietary supplements. The recall is being conducted because the products were not manufactured in compliance with the current Good Manufacturing Practice (cGMP) regulations for Dietary Supplements.
The recall covers all lots of the product distributed in the United States. The source text does not specify the quantity of units affected or the specific distribution channels.
Consumers who have purchased RegenErect herbal and dietary supplements should stop using the product. The source text does not provide specific instructions for disposal or return, but the recall is due to manufacturing non-compliance.
The recalled product
- Product
- RegenErect
- Manufacturer
- VivaCeuticals, Inc. dba Regeneca Worldwide
- Category
- Food — Dietary Supplements
- 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 (1)
- all lots
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by VivaCeuticals, Inc. dba Regeneca Worldwide 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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