The Food and Drug Administration (FDA) warned of a potential health hazard from ZOE US Inc.’s Daily 30+ Prebiotic Blend. This dietary supplement was voluntarily recalled by this Massachusetts-based company on December 4, 2024, for having a foreign object, including small pieces of metal and stones, in it. The FDA classified this as a Class II recall on December 24, 2024.
The classification of recall
A Class II recall is reserved for cases in which “the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.” In this case, adulteration with extraneous materials like metal fragments and stones could result in physical trauma including cuts inside the mouth, problems while digestion, or even blockages in the air passage. To date, no injuries or adverse health effects have been reported. However, out of an abundance of caution for consumer safety, ZOE US Inc. is taking this action.
Description of the recalled product
The Daily 30+ Prebiotic Blend product is packaged in 500g resealable pouches. The company has recalled 142 units distributed across 25 states that have an expiration date of October 31, 2025, and batch numbers 24269, 24287, and 24288. Specific details about the recall are given below:
- Recall Number: F-0316-2025
- Code Information: Expiration Date: 10/31/25; Batch Numbers: 24269, 24287, 24288
- Event ID: 95916
- Status: Ongoing
- Distribution Pattern: Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Kentucky, Maine, Massachusetts, Michigan, Minnesota, New Jersey, New Mexico, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin
Company’s response and consumer guidance
The Company posted the following announcement on their official website upon making its announcement. This shows, among other feelings, one of regret since, for it, nothing stands paramount above safety and quality.
“When we developed Daily30+, we sourced the highest quality ingredients, conducted a randomized controlled trial, and partnered with accredited suppliers to manufacture our whole-food prebiotic to the highest quality and safety standards. Unfortunately, one of our suppliers has let us down.”
The company further advised consumers:
“We have become aware of the potential presence of small stones and metal fragments in certain batches of Daily30+ at a critical control point in the supply chain. We are taking the precautionary measure of issuing a product recall.
“Please do not consume any Daily30+ you’ve already received. Instead, we ask that you compost or dispose of it,” the company continued.
People who have bought the supplement should “stop using it immediately” and check their product to see if it falls in one of the recalled lots. “If you have consumed any of the affected Daily30+, please rest assured that the vast majority of the product is free from foreign materials. However, if you experience any unusual effects or feel unwell, please consult your healthcare provider.”
Impact on subscriptions and refunds
ZOE US Inc. has told customers that the member subscriptions are in a paused state for a period of time until such time as the product is once more available. The company said it would refund money or replace items. They said:
“We sincerely apologize for the inconvenience and any frustration or concern this may cause. This is not the standard you should expect from ZOE products, and we are working diligently to resolve the issue as quickly as possible. Maintaining rigorous quality and safety standards across all aspects of production is a top priority for us.”
Consumer actions and safety measures
Consumers who have the product for their protection should do the following:
- Identify the product: Check the batch number and expiration date on your Daily 30+ Prebiotic Blend package to confirm whether it is part of the recalled lots.
- Stop using the product: If your product matches the recalled batch numbers, immediately cease consumption.
- Destroy the product: Compost or otherwise safely dispose of the product according to the company’s instructions.
- Contact the company: Consumers can contact ZOE US Inc. for a refund or replacement.
- Consult a healthcare professional: Consumers who have symptoms after consuming this product should contact their health care professional immediately.
Regulatory action and public health
The FDA continues to monitor this situation and will take all actions necessary to protect the public’s health. Consumers are advised to report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program.
