GM Manufacturing Recalls Saw Palmetto Supplements for cGMP Violations
GM Manufacturing is recalling 501 units of Saw Palmetto dietary supplements 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 and involves cGMP violations without reported illnesses or specific high-risk pathogens, fitting the criteria for moderate severity.
Plain-English summary
GM Manufacturing Inc. is recalling 501 units of Saw Palmetto dietary supplements packaged in glass bottles. The recall was initiated because the product was found to have significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.
The affected products have an expiration date of 11.2016. The recall is limited to distribution in California (CA).
Consumers who possess this product should stop using it and contact GM Manufacturing Inc. for further instructions or a refund.
The recalled product
- Product
- Saw Palmetto, Glass Bottle
- Manufacturer
- GM Manufacturing Inc.
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 501
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)
- EXP11.2016
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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