FDA Recalls Energique Herbal Supplements for Unapproved Drug Claims
Grato Holdings is recalling Energique herbal supplements because they are marketed as unapproved new drugs based on disease claims.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the nature of unapproved drug claims.
Plain-English summary
Grato Holdings, Inc. is recalling Energique, Herbal Supplement, Octocom, distributed by Energique, Inc. The recall involves 845 1-oz bottles and 59 1-oz bottles. The products were shipped to customers nationwide and in Canada.
The FDA has determined that these products are unapproved new drugs based on disease claims or routes of administration. The agency classifies this as a Class II recall.
Consumers who purchased these products should stop using them and return them to the place of purchase or contact the recalling firm for instructions.
The recalled product
- Product
- Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579
- Manufacturer
- Grato Holdings, Inc.
- Category
- Drug — Dietary Supplement
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- J20597
- J20840
- J21846
- J21849
- J21850
- J23464
- J23465
- J23466
- J23467
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Grato Holdings, Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Grato Holdings, Inc.
See all →- ModerateBotanical Herbal Supplement Recalled for Potential Yeast and Mold Contamination
FDA (Food) · 2024-07-10
- HighEnergique Mineral Magic Dietary Supplement recalled for yeast and mold contamination
FDA (Food) · 2024-07-10
- ModerateV-Force Homeopathic Recalled for Incorrect Ingredient Formulation
FDA (Drugs) · 2023-11-15
- HighWalgreens Earache Drops recalled for microbial contamination of non-sterile product
FDA (Drugs) · 2022-06-15
- HighHomeopathic EarAche Ear Drops Recalled for Microbial Contamination
FDA (Drugs) · 2022-06-15
Same hazard · unapproved drug
See all →- CriticalBuy-Herbal Recalls Kian Pee Wan Capsules for Undeclared Drug Ingredients
FDA (Drugs) · 2026-08-19
- SevereMR. 7 Super capsules recalled as Class I over undeclared sildenafil
FDA (Drugs) · 2026-03-11
- SevereMojo Max Fusion capsules recalled as Class I over undeclared drug ingredients
FDA (Drugs) · 2026-03-11
- SevereSilintan herbal pills recalled as Class I for undeclared meloxicam
FDA (Drugs) · 2026-03-11
- SevereAgebox iKids-Growth Day Formula Capsules Recalled Over Undeclared Drug Ingredient
FDA (Drugs) · 2026-03-04
Similar recalls
- SevereFDA Recalls Energique Homeopathic Skin Spray Due to Microbial Contamination
FDA (Drugs) · 2016-01-27
- HighApotheca Energique Gastrozyme Recalled for Potential Chloramphenicol Contamination
FDA (Food) · 2013-11-20
- HighEnergique Mineral Magic Dietary Supplement recalled for yeast and mold contamination
FDA (Food) · 2024-07-10
- SevereFDA Recalls Energique Homeopathic Pain Spray for Microbial Contamination
FDA (Drugs) · 2016-01-27
- ModerateEnergique Homeopathic Spray Recalled for Microbial Contamination
FDA (Drugs) · 2016-01-27
- ModerateGrato Holdings Recalls Homeopathic Energy Catalyst for Undeclared API
FDA (Drugs) · 2020-11-25