FDA recall F-0504-2024

Product

TYSON 2.0, TYSON TONIC KAVA & KRATOM BLEND, Mocha, 2oz (60ml), Supplement Facts, Kava Root Extract (30%) 1200mg, Kratom Leaf Extract (30%) 120mg, (Providing 36mg Mitragynine), www.tyson20global.com, LGNDS, LLC, UPC: 850043583608, POWERED BY LGNDS, 12 bottles of 2oz each per case.

Reason for recall

Finished product contains kratom (an unapproved food additive) and pH is over 5.0. The process authority letter classified product as acidified and pH cannot exceed 3.30.

Distribution

U.S. distribution only.

Key facts

Status

Terminated

Initiation date

2023-10-13

Report date

2023-12-20

Termination date

2024-01-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0504-2024