Recall record at a glance
| Official record | F-1189-2016 |
|---|---|
| Category | Food Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Iowa Select Herbs LLC |
| Report date | May 11, 2016 |
| Recall initiation date | Sep 11, 2015 |
| Quantity | (a) 1 bottle, (b) 26 bottles, (c) 2 bottles |
| Location | Cedar Rapids, IA, United States |
Official product description
Iowa Select Herbs LLC, Kava Kava Root (Piper methysticum), www.iowaselectherbs.com, (a) 2 fl. Oz., (b) 4 fl. Oz., (c) 16 fl. Oz., Cedar Rapids, IA 52402
Why the product was recalled
Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.
Distribution information
The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: FDA Mandated. Initial notification: Press Release.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.