GM Manufacturing Recalls Noni Supplement Capsules for cGMP Violations
GM Manufacturing is recalling Noni Supplement Capsules due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
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 2/5 (Moderate).
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 involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source cites cGMP violations without reporting specific illnesses or injuries, aligning with a Moderate severity rating for regulatory non-compliance.
Plain-English summary
GM Manufacturing Inc. is recalling Noni Supplement, Capsules. The recall was initiated due to significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.
The affected product consists of 200,100 units of Noni Supplement, Capsules. The distribution was limited to California (CA). The code information indicates a date range of September 23, 2013, to September 30, 2013.
Consumers who have purchased this product should stop using it and contact GM Manufacturing Inc. for further instructions or a refund.
The recalled product
- Product
- Noni Supplement, Capsules
- Manufacturer
- GM Manufacturing Inc.
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 200,100
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)
- 9/23/13 > 9/30/13
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 46 recalled by GM Manufacturing 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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