Class IIOngoing · reported 2020-12-23

PHARMORIGINS CORE with Natural Orange Flavor NATURAL ENERGY and IMMUNE HEALTH Dietary…

Fusion Health and Vitality LLC recalled this product and the FDA reported the enforcement action on 23 December 2020 as Class II. The recall was initiated by the firm. The firm is recalling their products due the unapproved use of a food additive and unapproved marketing statements

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product: PHARMORIGINS CORE with Natural Orange Flavor NATURAL ENERGY and IMMUNE HEALTH Dietary Supplement 30 Servings (45g) Supplement Facts***Hordenine HCL*** Manufactured by: Fusion Health Vitality, LLC 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004 888.964.5327 UPC 7 28028 21054 5
UPC: 728028210545
Reason for recall: The firm is recalling their products due the unapproved use of a food additive and unapproved marketing statements
Recalling firm: Fusion Health and Vitality LLC
Firm location: Alpharetta, Georgia, United States
Classification: Class II
Status: Ongoing
Recall number: F-0180-2021
Quantity: 10,000/45g jars
Distribution: Product was shipped nationwide to all 50 states
Initiated: 17 November 2020
Reported by FDA: 23 December 2020
Firm notified by: Letter
Product codes: Lot # s: 200313, 200321, 200326, 200402, 200406, 200410, 200414, 200416, 200424, 200501, 200525, 200527, 200604 & 200610.

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
This record is the only one the FDA opened for its recall event, so it covers a single product code.
This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
The FDA published the enforcement report 5 weeks after the firm began the recall.
Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.

What this recall was for

Unapproved ingredients

An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.

A preventive controls plan covers an unapproved ingredient under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.

21 CFR 111: Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.
21 CFR 117 subpart G: Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.

Filed under dietary supplements. A product can sit in more than one.

Other dietary supplements recalls for the same reason

These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.

Reported	Product	Firm	Reason	Class
2026-07-29	Vintage Roots Root Beer Syrup, packaged in glass bottle. Net Wt. 8oz. (236.6 mL). Distributed by Vintage Roots, PO Box 12, Brady, MT 59416. The product label declares: Ingredients: Filtered Water, Pure Cane Sugar, Sassafras Bark, Burdock Roots, Wild Cherry Bark, Molasses, Fresh Lemon Juice, Star Anise, Coriander Seeds, Whole Clove, Wintergreen Extract (no alcohol).	Vintage Roots LLC	Unapproved food additive: sassafras bark.	Class II
2026-07-29	Modern Warrior Ready, Dietary Supplement, 60 CAPSULES	Modern Warrior Life, LLC	FDA analysis revealed the presence of unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam.	Class I
2026-04-15	Blue Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Entire Pouch 30 Minutes before Intercourse. Produced by Blue Bull Corporation Made In USA. UPC Code 707443349917	Pure Vitamins and Natural Supplements, LLC	FDA analysis revealed the presence of undeclared sildenafil	Class I
2026-04-15	Red Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Entire Pouch 30 Minutes before Intercourse. Produced by Red Bull Corporation. Turkey www.redbullhoney.com UPC Code 9554100205595	Pure Vitamins and Natural Supplements, LLC	FDA analysis revealed the presence of undeclared sildenafil	Class I
2025-12-31	Organic Ginger Root Herbal Supplement, Natural anti-inflammatory properties, supports gut, increases circulation, 50 capsules/560 mg, packaged in a plastic bag	A New Life Herbs, LLC	Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label	Class II
2025-12-31	Chaga Mushroom Herbal Supplement, 1:5 Alcohol Double Extract, Supports a healthy immune system with anti-cancer properties; packaged in a 2 oz. glass dropper bottle, UPC 284588087831	A New Life Herbs, LLC	Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label	Class II
2025-12-31	Sinus Cap Herbal Supplement, Herbs containing antibiotic, drying, expectorant, and emollient properties, Fenugreek, Thyme, Oregon Grape Root, & Bentonite Clay, 50 capsules/510 mg; packaged in a plastic bag	A New Life Herbs, LLC	Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label	Class II
2025-12-31	Anti-virus Herbal Supplement, 1:5 Alcohol Tincture, Helps to stop viral replication, expectorant properties, Contains: Forsethia blossoms, Sumac berries, Pine needles; packaged in a 2 oz. glass dropper bottle, UPC 283162814429	A New Life Herbs, LLC	Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label	Class II

All 2020 recalls · All FDA food recall data

21 CFR 111 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.