Safety Report: Multiple Dietary Supplements recalled due to Undeclared Artificial Dyes, USA

United States

Preventics, Inc. is recalling multiple dietary supplements due to undeclared artificial dyes, Allura Red (Red No. 40) and Brilliant Blue (Blue No. 1), used in gelatin capsules. The products were distributed nationwide in the United States.

The recall includes:
- Product: Prothin
- Description: Dietary supplement – Seven packets containing 2 tablets and 4 capsules each
- Product Quantity: 1,696 bags
- Code Information: 12131

- Product: Super ProTHIN Plus
- Description: Dietary supplement – Seven packets (2 tablets & 4 capsules each) plus one packet with 14 NutriLean capsules
- Product Quantity: 55,080 pills
- Code Information: 12131

- Product: Protrim Plus
- Description: Dietary supplement – 90 capsules per bottle
- Product Quantity: 763 containers
- Code Information: 21634-9

- Product: Probese Caps
- Description: Dietary supplement with Iron – 90-count bottles
- Product Quantity: 112,506 pills
- Code Information: 21874-19, 21874-20, 21874-21, 21874-22, 21874-23, 21874-24, 21874-25

- Product: NutriLean
- Description: Dietary supplement capsules
- Product Quantity: 94,190 capsules
- Code Information: 21745-11, 21745-12, 21745-13, 21745-14, 21745-15

- Product: Rodex Forte
- Description: Dietary supplement – 90 capsules per bottle
- Product Quantity: 42,280 capsules
- Code Information (Batch codes): 21635-21, 21635-22, 21635-23, 21635-34

The recall was voluntarily initiated by Preventics on April 30, 2025, and classified as Class III on June 25, 2025. The issue was discovered through an internal review.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source:
www.accessdata.fda.gov/scripts/ires/index.cfm
www.accessdata.fda.gov/scripts/ires/index.cfm
www.accessdata.fda.gov/scripts/ires/index.cfm
www.accessdata.fda.gov/scripts/ires/index.cfm
www.accessdata.fda.gov/scripts/ires/index.cfm
www.accessdata.fda.gov/scripts/ires/index.cfm