enterade Advanced Oncology Formula Recalled for Potential Mold and Spoilage

Agency Publication Date: June 22, 2023

Summary

ENTRINSIC HEALTH SOLUTION INC is recalling 43,336 bottles of enterade Advanced Oncology Formula (Original Vanilla Flavor). This medical food, intended to help manage and maintain gastrointestinal function in oncology patients, is being recalled because the product may develop mold and spoil. While no incidents or injuries have been reported to date, the manufacturer initiated the recall as a precautionary measure.

Risk

The product has the potential to develop mold and spoil. Consuming spoiled or moldy food products can lead to gastrointestinal distress or other health complications, which poses a particular risk to oncology patients who may have compromised immune systems.

What You Should Do

This recall involves enterade Advanced Oncology Formula in Original Vanilla Flavor sold in 8 FL OZ (237 mL) bottles.
To identify if your product is affected, check the lot number and expiration date printed on the bottle. The affected lots are: OEV24122 (Exp: 8/29/24), OEV24222 (Exp: 8/30/24), OEV24322 (Exp: 8/31/24), OEV24422 (Exp: 9/1/24), OEV24522 (Exp: 9/2/24), OEV24922 (Exp: 9/6/24), OEV25022 (Exp: 9/7/24), OEV25122 (Exp: 9/8/24), OEV25222 (Exp: 9/9/24), and OEV25522 (Exp: 9/12/24).
Return the product to the place of purchase for a full refund, throw it away, or contact ENTRINSIC HEALTH SOLUTION INC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Return the product to the place of purchase for a full refund, or contact the manufacturer or supplier for further instructions

Option 2: Dispose of Product

How to: Throw the product away.

Affected Products

Product: enterade Advanced Oncology Formula (8 FL OZ)

Variants: Original Vanilla Flavor, Medical Food

Lot Numbers:

OEV24122 (Exp: 8/29/24)

OEV24222 (Exp: 8/30/24)

OEV24322 (Exp: 8/31/24)

OEV24422 (Exp: 9/1/24)

OEV24522 (Exp: 9/2/24)

OEV24922 (Exp: 9/6/24)

OEV25022 (Exp: 9/7/24)

OEV25122 (Exp: 9/8/24)

OEV25222 (Exp: 9/9/24)

OEV25522 (Exp: 9/12/24)

Medical food for patients under the supervision of a physician; helps manage and maintain GI function; refrigerate after opening.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92408

Status: Resolved

Manufacturer: ENTRINSIC HEALTH SOLUTION INC

Sold By: Authorized Medical Food Distributors

Manufactured In: United States

Units Affected: 43,336 bottles

Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves enterade Advanced Oncology Formula in Original Vanilla Flavor sold in 8 FL OZ (237 mL) bottles.

To identify if your product is affected, check the lot number and expiration date printed on the bottle. The affected lots are: OEV24122 (Exp: 8/29/24), OEV24222 (Exp: 8/30/24), OEV24322 (Exp: 8/31/24), OEV24422 (Exp: 9/1/24), OEV24522 (Exp: 9/2/24), OEV24922 (Exp: 9/6/24), OEV25022 (Exp: 9/7/24), OEV25122 (Exp: 9/8/24), OEV25222 (Exp: 9/9/24), and OEV25522 (Exp: 9/12/24).

Return the product to the place of purchase for a full refund, throw it away, or contact ENTRINSIC HEALTH SOLUTION INC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Affected Products

Product: enterade Advanced Oncology Formula (8 FL OZ)

Variants: Original Vanilla Flavor, Medical Food

Lot Numbers:

OEV24122 (Exp: 8/29/24)

OEV24222 (Exp: 8/30/24)

OEV24322 (Exp: 8/31/24)

OEV24422 (Exp: 9/1/24)

OEV24522 (Exp: 9/2/24)

OEV24922 (Exp: 9/6/24)

OEV25022 (Exp: 9/7/24)

OEV25122 (Exp: 9/8/24)

OEV25222 (Exp: 9/9/24)

OEV25522 (Exp: 9/12/24)

Medical food for patients under the supervision of a physician; helps manage and maintain GI function; refrigerate after opening.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92408

Status: Resolved

Manufacturer: ENTRINSIC HEALTH SOLUTION INC

Sold By: Authorized Medical Food Distributors

Manufactured In: United States

Units Affected: 43,336 bottles