NaturesPlus ULTRA T-MALE Maximum Strength Testosterone Boost for Men 60 Bi-layer Tablets
Summary
The FDA issued a Class III for NaturesPlus ULTRA T-MALE Maximum Strength Testosterone Boost for Men 60 Bi-layer by Natural Organics, Inc.. Reason: Product is missing the ingredient TongKat Ali and has additional Rhodiola Rosea.
Details
Source
Food Recall
External ID
F-1519-2024
Action Date
2024-08-07
Status
Terminated
Category
food
Product Description
NaturesPlus ULTRA T-MALE Maximum Strength Testosterone Boost for Men 60 Bi-layer Tablets
Lot/Code Info: Lot: 1381667 and 1381994 Best By 03/2028 for both lots UPC Codes: 0 97467 48716 1 Product No. 48716
Quantity Affected: 11,496 bottles (Total)
Reason for Recall
Product is missing the ingredient TongKat Ali and has additional Rhodiola Rosea
Distribution
US Nationwide, Germany, Trinidad, Bermuda, Africa, Greece, Panama
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-31
Company
Melville, NY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 105 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Natural Organics, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Natural Organics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Natural Organics, Inc. have FDA actions?
Natural Organics, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1519-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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