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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Food
Food & Beverages/Dietary Supplements

Legere Pharmaceuticals Dietary Supplements Recalled for Undeclared Food Dyes

Agency Publication Date: June 25, 2025
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Summary

Preventics, Inc., doing business as Legere Pharmaceuticals, is recalling 306,515 units of several dietary supplement products because they contain undeclared Allura Red (Red No. 40) and Brilliant Blue (Blue No. 1) used in the gelatin capsules. The recall includes products branded as Prothin, Super ProTHIN Plus, Protrim Plus, Probese Caps, NutriLean, and Rodex Forte. No incidents or injuries have been reported to date. Consumers should return these products to the place of purchase for a full refund or throw them away.

Risk

Consumers who have a severe sensitivity to food dyes like Red No. 40 or Blue No. 1 run the risk of an allergic or adverse reaction if they consume these supplements.

What You Should Do

  1. This recall affects Legere Pharmaceuticals dietary supplements including Prothin, Super ProTHIN Plus, Protrim Plus, Probese Caps, NutriLean, and Rodex Forte. These products do not have UPC codes and are sold in various bottle sizes and packet sets.
  2. Check your supplement packaging for the following lot or batch numbers: 12131, 21634-9, 21874-19, 21874-20, 21874-21, 21874-22, 21874-23, 21874-24, 21874-25, 21745-11, 21745-12, 21745-13, 21745-14, 21745-15, 21635-21, 21635-22, 21635-23, and 21635-34.
  3. Return the product to the place of purchase for a full refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away.

Affected Products

Product: Prothin (7 Packets)
Variants: 7 Packets containing 2 tablets and 4 capsules
Lot Numbers:
12131

Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260

Product: Super ProTHIN Plus
Variants: 7 Packets with 2 tablets & 4 Capsules and 1 packet with 14 Nutrilean capsules
Lot Numbers:
12131

Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260

Product: Protrim Plus (90 capsules)
Variants: 90 capsule/bottles
Lot Numbers:
21634-9

Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260

Product: Probese Caps (90 count)
Variants: 90-count bottles, Contains Iron
Lot Numbers:
21874-19
21874-20
21874-21
21874-22
21874-23
21874-24
21874-25

Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260

Product: NutriLean
Variants: Capsules
Lot Numbers:
21745-11
21745-12
21745-13
21745-14
21745-15

Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260

Product: Rodex Forte (90 capsules)
Variants: 90 capsule bottles
Lot Numbers:
21635-21
21635-22
21635-23
21635-34

Batch codes used as lot identifiers.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96839
Status: Resolved
Manufacturer: Preventics, Inc. dba Legere Pharmaceuticals
Sold By: Legere Pharmaceuticals
Manufactured In: United States
Units Affected: 6 products (1696 bags; 55,080 pills; 763 Containers; 112,506 pills; 94,190 capsules; 42,280 capsules)
Distributed To: Nationwide

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 ยท 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.