Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Oct 18, 2019 (7 years ago)

BIOGENYX True Full Spectrum CBD Oil Wintergreen

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Marketed without an Approved NDA/ANDA

Cause type: Unapproved drug

The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.

What was recalled

BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

Recalling firm
Basic Reset Inc.
Origin
TN, United States
Initiated by
FDA Mandated
FDA recall number
D-0195-2020 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by Basic Reset Inc.

All 2019 recalls

Other unapproved drug recalls from 2019

All unapproved drug recalls