Octocom Herbal Supplement (Grato Holdings) – Unapproved Drug Claims (2018)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579
Brand
Grato Holdings, Inc.
Lot Codes / Batch Numbers
J20597, J20840, J21846, J21849, J21850, J23464, J23465, J23466, J23467
Products Sold
J20597, J20840, J21846, J21849, J21850, J23464, J23465, J23466, J23467
Grato Holdings, Inc. is recalling Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579 due to Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 6, 2026