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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
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