Class IITerminated in FDA datasetJul 1, 2014

Kr8om Max3 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 3 capsules; Kr8om Max10 All-Natural Extraction, Formulation, and Distribution by…

Recalling firm: Nuevotanicals

Why it was recalled

This products contain Kratom.

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ProductKr8om Max3 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 3 capsules; Kr8om Max10 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 10 capsules; Capsules are packed in a round, clear plastic screw-on lid container. Dosage is "1 capsule after a meal", each capsules is "4.4 g leaf equiv".

FDA code information

All products manfactured since 6/1/2011

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Full FDA record and distribution details

Original product description

Kr8om Max3 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 3 capsules; Kr8om Max10 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 10 capsules; Capsules are packed in a round, clear plastic screw-on lid container. Dosage is "1 capsule after a meal", each capsules is "4.4 g leaf equiv".

Recall details

Recall number
F-2413-2015
Event ID
68705
FDA status
Terminated
Initiated
Jul 1, 2014
Reported
Jun 17, 2015
Classified
Jun 8, 2015
Terminated
Mar 2, 2017
Quantity
1,372 units
Location
Fort Worth, TX, United States
Initiation type
Voluntary: Firm initiated
Notification
Letter

Where it was distributed

Alabama, Arizona, California, Florida, Illinois, Nevada, New York, Ohio, Oklahoma, Oregon, Texas, and Virginia.

FDA source record · F-2413-2015

Data updated September 16, 2026. View official FDA data ↗

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