GM Manufacturing Recalls Affirm XL Blister Packs for cGMP Violations
GM Manufacturing is recalling 4,000 units of Affirm XL dietary supplements in California 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 and involves cGMP violations without reported illnesses or specific high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
GM Manufacturing is voluntarily recalling 4,000 units of Affirm XL, Blister Packs. The recall is being conducted because the product was found to have significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.
The affected product was distributed in California. No specific lot numbers are associated with this recall. The agency has classified this recall as Class II.
Consumers who have purchased Affirm XL, Blister Packs from GM Manufacturing should stop using the product and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Affirm XL, Blister Packs
- Manufacturer
- GM Manufacturing Inc.
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 4,000
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)
- No lot numbers
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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