The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Food)·F-2265-2014·Announced 2014-08-06

GM Manufacturing Recalls BTI Lean Formula Dietary Supplements

GM Manufacturing is recalling BTI Lean Formula 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, which typically involves a temporary or medically reversible adverse health consequence. The source cites cGMP violations without reporting specific illnesses or injuries, fitting the Moderate severity criteria for regulatory non-compliance without immediate severe harm reports.

Plain-English summary

GM Manufacturing Inc. is voluntarily recalling BTI Lean Formula, 400cc HDPE Bottle, a dietary supplement. 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 recall involves 1,000 units of the product. The specific distribution area is California (CA). The affected product has the code LT7345 and expiration date EX10.16.

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
BTI Lean Formula, 400cc HDPE Bottle
Manufacturer
GM Manufacturing Inc.
Category
Food — Dietary Supplements
Hazard
Affected units
1,000

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)

  • LT7345 EX10.16

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.

See all 46 products in this recall →

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