TYSON 2.0, TYSON TONIC KAVA & KRATOM BLEND, Mocha, 2oz (60ml), Supplement Facts, Kava Root Extract (30%) 1200mg, Kratom
Summary
The FDA issued a Class II for TYSON 2.0, TYSON TONIC KAVA & KRATOM BLEND, Mocha, 2oz (60ml), Supplement Facts, by LGNDS LLC. Reason: Finished product contains kratom (an unapproved food additive) and pH is over 5.0. The process authority letter classified product as acidified and pH.
Details
Source
Food Recall
External ID
F-0504-2024
Action Date
2023-12-20
Status
Terminated
Category
food
Product Description
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.
Lot/Code Info: Lot #U19231550, BEST BY: 11 JUL 24
Quantity Affected: 15,000 units of 2oz each
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-13
Company
Miami, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 food recalls issued in the same week, part of 204 food-related FDA actions this month.
LGNDS LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LGNDS LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LGNDS LLC have FDA actions?
LGNDS LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0504-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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