FDA Drug Recalls

Recalls / Class I

Class ID-1005-2018

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

Product

Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical Red Borneo, 1oz, 250g, kg Gaia Ethnobotanical Red Dragon, 1oz, 250g, 1kg Gaia Ethnobotanical Red Horn, 1oz, 250g, 1kg Gaia Ethnobotanical Red Kapuas Hulu 1oz, 250g, 1kg Gaia Ethnobotanical Red MD, 1oz, 250g, 1kg Gaia Ethnobotanical Red Thai, 1oz, 250g,. 1kg Gaia Ethnobotanical Super Green Malay 1oz, 250g, 1kg Gaia Ethnobotanical White Borneo 1oz, 250g, 1kg Gaia Ethnobotanical White Horn, 1 oz, 250g, 1kg Gaia Ethnobotanical White MD, 1 oz, 250 g, 1 kg Gaia Ethnobotanical White Thai, 1oz, 250 g, 1 kg Gaia Ethnobotanical Yellow Thai, 1oz, 250 g, 1kg Gaia Ethnobotanical Yellow Vietnam 1oz, 250g, 1kg

Affected lot / code info
Lot # 0102031800

Why it was recalled

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Recalling firm

Firm
Gaia Ethnobotanical LLC
Notification channel
Press Release
Type
Voluntary: Firm initiated
Address
2752 Botticelli Dr, Henderson, Nevada 89052-3107

Distribution

Quantity
unknown
Distribution pattern
Nationwide.

Timeline

Recall initiated
2018-06-20
FDA classified
2018-07-26
Posted by FDA
2018-07-18
Terminated
2022-01-26
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1005-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.