Health One Pharmaceuticals Recalls Reishi Spore Gen Dietary Supplements
Health One Pharmaceuticals is recalling Reishi Spore Gen dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible health consequences. The source text cites cGMP violations without reporting specific illnesses or injuries, aligning with a Moderate severity rating.
Plain-English summary
Health One Pharmaceuticals is voluntarily recalling Reishi Spore Gen, 90 Capsules, 500mg. The recall was initiated because the dietary supplements were found to have significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.
The affected product consists of 5,013 units. The products were distributed nationwide in the United States, specifically in California, Tennessee, Washington, and Idaho. Additionally, the products were distributed worldwide in Hong Kong, Vietnam, China, and Singapore. The product code is 8851.
Consumers who have purchased this product should stop using it and contact Health One Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- Reishi Spore Gen, 90 Capsules, 500mg
- Manufacturer
- Health One Pharmaceuticals Inc
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 5,013
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 (1)
- 8851
Distribution
Part of a larger recall action
This product is one of 147 recalled by Health One Pharmaceuticals 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 147 products in this recall →Related recalls
Same manufacturer · Health One Pharmaceuticals Inc
See all →- ModerateHealth One Pharmaceuticals Recalls Breathe Free Dietary Supplements
FDA (Food) · 2015-04-08
- ModerateHealth One Pharmaceuticals Recalls O.T.I.V Dietary Supplements
FDA (Food) · 2015-04-08
- ModerateHealth One Pharmaceuticals Recalls Bone Essense Dietary Supplement
FDA (Food) · 2015-04-08
- ModerateHealth One Pharmaceuticals Recalls Cholesterol Formula Due to cGMP Violations
FDA (Food) · 2015-04-08
- ModerateHealth One Pharmaceuticals Recalls Tri-Circulator Dietary Supplement
FDA (Food) · 2015-04-08
Same hazard · cGMP violation
See all →- HighHand Sanitizer Recalled Due to Manufacturing Practice Deviations
FDA (Drugs) · 2023-02-08
- ModeratePyrogenium Homeopathic Remedy Recalled for Manufacturing Process Violations
FDA (Drugs) · 2022-06-22
- ModerateDrug Recall: PAINAID Tablets for Manufacturing Deviations
FDA (Drugs) · 2022-02-09
- ModerateDrug Recall: PEPTIME Energy Caffeine Tablets cGMP Violations
FDA (Drugs) · 2022-02-09
- ModerateCalvin Scott Recalls Diethylpropion Tablets Due to Stability Deviations
FDA (Drugs) · 2020-10-14