The Recall Desk
ModerateFDA (Food)·F-2259-2014·Announced 2014-08-06

GM Manufacturing Recalls Bitter Melon Supplements for cGMP Violations

GM Manufacturing is recalling 380 units of Bitter Melon 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 and involves cGMP violations without specific reports of illness or injury, fitting the criteria for moderate severity.

Plain-English summary

GM Manufacturing Inc. is recalling 380 units of Bitter Melon dietary supplements, packaged in 225cc HDPE bottles. The recall is being conducted due to significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

The affected products have an expiration date of October 2016 (EXP10.2016). The recall is limited to distribution in California (CA).

Consumers who possess these products should stop using them and contact the recalling firm for further instructions or a refund.

The recalled product

Product
Bitter Melon, 225cc HDPE Bottle
Affected units
380

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)

  • EXP10.2016

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.

See all 46 products in this recall →