Multi-event June 2018 FDA Recall Drug by Gaia Ethnobotanical Llc

This Multi-event Class I drug recall was voluntarily initiated by Gaia Ethnobotanical Llc on June 20, 2018 for the product Drug. The FDA reported the reason for recall as microbal contamination of non-sterile product; fda analysis found salmonella contamination. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0993-2018 TERMINATED D-0999-2018 TERMINATED D-1009-2018 TERMINATED D-0998-2018 TERMINATED D-1002-2018 TERMINATED D-0996-2018 TERMINATED D-0994-2018 TERMINATED D-1015-2018 TERMINATED D-1003-2018 TERMINATED D-1004-2018 TERMINATED D-0995-2018 TERMINATED D-1008-2018 TERMINATED D-1001-2018 TERMINATED D-1006-2018 TERMINATED D-1013-2018 TERMINATED D-0997-2018 TERMINATED D-1005-2018 TERMINATED D-1016-2018 TERMINATED D-1014-2018 TERMINATED D-1010-2018 TERMINATED D-1007-2018 TERMINATED D-1000-2018 TERMINATED D-1012-2018 TERMINATED D-1011-2018 TERMINATED

Recall Number: D-0993-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Bali Gold, 1oz, 250g 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-0999-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Green Malay, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800, exp

Recall Number: D-1009-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Red Kapuas Hulu , 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-0998-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Green Kapuas Hulu, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1002-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-0996-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Green Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-0994-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Elephant, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1015-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Yellow Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1003-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1004-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-0995-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Ganesh, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1008-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Red Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1001-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Green Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1006-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1013-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-0997-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1005-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1016-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Yellow Vietnam, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1014-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, White Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1010-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1007-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Red Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1000-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, Green MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800, exp

Recall Number: D-1012-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, White Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800

Recall Number: D-1011-2018

Reason for Recall
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Initiated
06-20-2018
Reported
07-18-2018
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80343
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gaia Ethnobotanical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the product.
Gaia Kratom (mitragyna speciosa) powder, White Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Batch or Lot Expiration Information

Lot# 0102031800