Immediate Recall of Ozona Organics Probiotics Issued

The FDA, along with Ozona Organics, LLC, has issued a recall of select lots of GoHealthy Liquid Probiotics. The digestive health supplements marketed for use by infants, toddlers, kids, and adults have the potential to cause serious illness due to microbial contaminations. All lots of the company’s line of probiotics for pigs, horses, dogs, and cats are being recalled as well.

As of the writing of this notice, no adverse effects have yet been reported.

SUMMARY

Date of Recall:

Announced: August 1, 2023

Public Notification: August 1, 2023

Name(s) of Drug:

GoHealthy Liquid Probiotics

Ozona Organics Probiotics

Company Name:

Ozona Organics, LLC

Drug Indication:

Digestive Health

 

Product Description

The probiotics marketed for human consumption come packaged in 2-oz or 4-oz blue, glass bottles, or 16-oz blue, plastic bottles. The line of products marketed for animal use comes in 1-gallon white, plastic bottles.

Products were distributed online at www.ozonaorganics.com, www.gohealthy.us, www.walmart.com, and www.amazon.com.

Reason for Recall

Ozona Organics, LLC has found a high amount of water activity in the formula. This could lead to unwanted microbial growth and therefore illness in consumers who ingest the product.

Impacts

Consumers who continue to ingest the probiotics could experience illness leading to symptoms such as:

• Nausea
• Vomiting
• Diarrhea
• Fever
• Fatigue
• Dizziness
• Loss of Appetite
• Abdominal Pain
• Dehydration

Symptoms could last up to 7 days.

Lot Information

Consumers should locate the bottle in which the medication comes to compare lot numbers, manufacturing dates, and expiration dates with the chart below. If you find your lot number, manufacturing date, and expiration date on the chart below, your medication is affected by the recall and you will need to take additional steps in order to ensure that your health is not affected and to take part in recall procedures.

All lots of Ozona Organics probiotics for dogs, cats, and pigs are included in the recall.

Product Description	Lot Number	Manufacturing Date	Expiration Date
Ozona Probiotics for Digestive Health	011122	11/01/2021	11/01/2023
Ozona Probiotics for Digestive Health	011228	12/28/2021	12/28/2023
Ozona Probiotics for Digestive Health	020810	08/10/2022	08/10/2024
Ozona Probiotics for Digestive Health	021115	11/15/2022	11/15/2024
Ozona Probiotics for Digestive Health	022023	12/15/2022	12/15/2024
Ozona Probiotics for Digestive Health	030115	01/15/2023	01/15/2025
Ozona Probiotics for Digestive Health	030301	03/01/2023	03/01/2025

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

1. 1. Call your doctor right away and report any changes in your symptoms.
   2. Continue to monitor your health for any adverse symptoms over the next week and notify your physician if any concerns are noted.
   3. Consumers should contact Ozona Organics, LLC at 1-325-203-4026. They are available Mon-Fri from 9:00am to 4:00pm (CT).
   4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
   5. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

Retailer

1. 1. Examine all inventory and remove stock that is affected by the recall immediately.
   2. Contact Ozona Organics, LLC at 1-325-203-4026. Notify them of any recalled batches that have already been sold to consumers.
   3. Notify affected consumers of recalled batches that they have already or will receive.
   4. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

Wholesaler

1. 1. Examine all inventory and remove stock that is affected by the recall immediately.
   2. Contact Ozona Organics, LLC at 1-325-203-4026. Notify them of any recalled batches that have already been shipped to retailers.
   3. Notify affected retailers of recalled batches that they have already or will receive.
   4. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

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Tammy McKinney, RN, creator of HelpfulHospiceNurse is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!