Recall notice · FDA Recall Press Releases

Guru Inc.: FDA Recall Notice (Jul 16, 2024)

Agency action: Jul 16, 2024Record ID: fda_recall_p-b7c0280564e778de
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What happened

Original notice title

GURU INC. Issues Voluntary Nationwide Recall of Infla-650 Herbal Dietary Supplement Capsules Due to Hidden Drug Ingredients

From the archived source record

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. More Recalls, Market Withdrawals, & Safety Alerts Recalls, Market Withdrawals, & Safety Alerts Recall Resources Enforcement Reports Industry Guidance For Recalls Major Product Recalls FOR IMMEDIATE RELEASE – 07/16/2024 – Lilburn, GA, GURU INC. is voluntarily recalling Infla-650 Herbal Dietary Supplement Capsules, Lot No. IN-032, 700 mg to the consumer/user level. Infla-650 capsules has been found to be tainted with acetaminophen, diclofenac and phenylbutazone , which are not listed on the label. Products containing acetaminophen, diclofenac and phenylbutazone cannot be marketed as dietary supplements. Infla-650 Herbal Dietary Supplement Capsules is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall. Risk Statement: Use of the product poses a serious threat to consumers because it may result in unintentional acetaminophen overdose, especially if it is used in combination with other acetaminophen-containing products. Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death. People who experience unintentional acetaminophen overdose may not seek prompt medical attention because the symptoms of liver damage can take several days to emerge, even in severe cases. Acetaminophen may also cause serious skin reactions. Symptoms may include skin reddening, rash, and blisters. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products

What the official notice says to do

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Status and source details

Status recorded in the archive
Published recall notice
Source checked
Jul 16, 2026
Record revision
3bf62b1b57c6

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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What is affected

Product
Infla-650 Herbal Dietary Supplement Capsules; GURU INC. Issues Voluntary Nationwide Recall of Infla-650 Herbal Dietary Supplement Capsules Due to Hidden Drug Ingredients
Company
Guru Inc.
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.