ZMB Enterprises — Class I: Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplement
ZMB Enterprises has initiated an ongoing Class I recall for its 'Addall XR Shot' liquid dietary supplement. The recall was issued because the product contains 1,4-DMAA, Phenylethylamine, and Phenibut.
This recall affects ZMB Enterprises and entities involved in the distribution or retail of the Addall XR Shot liquid dietary supplement. It also impacts regulatory and quality functions within the dietary supplement industry responsible for ingredient safety and compliance.
A Class I designation is the FDA's most serious recall category, indicating a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death. The presence of 1,4-DMAA, Phenylethylamine, and Phenibut suggests that the FDA views these substances as significant safety risks or unauthorized additives in dietary supplements. This enforcement action serves as a signal that the agency is actively monitoring and removing products containing these specific compounds from the market.
Quality and regulatory teams should immediately verify if these specific ingredients—1,4-DMAA, Phenylethylamine, and Phenibut—are present in their dietary supplement formulations. Affected product should be quarantined, and supply chain audits should be conducted to ensure raw material specifications align with current regulatory requirements for dietary ingredients.
Class I. Reason: The product contains 1,4-DMAA, Phenylethylamine and Phenibut.. Product: Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplement. Firm: ZMB Enterprises (Carlsbad CA United States). Status: Ongoing.
Open in openFDA / FDA.gov