The Recall Desk
ModerateFDA (Drugs)·D-1198-2018·Announced 2018-09-26

Beaumont Bio-Med Recalls Colds & Flu Response Homeopathic Formula

Beaumont Bio-Med is recalling Colds & Flu Response Homeopathic Formula due to potential microbial contamination from manufacturing deviations.

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 the source text describes 'possible microbial contamination' without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Beaumont Bio-Med, Inc. is recalling 314 bottles of Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle. The product is distributed nationwide in the USA. The recall involves specific lots: 042816C (Exp 04/2019) and 112317K (Exp 11/2020), identified by NDC 58066-7012-7.

The recall was initiated because the product was manufactured by a contract manufacturer under conditions that resulted in Current Good Manufacturing Practice (CGMP) deviations. These deviations could result in possible microbial contamination.

Consumers who have purchased this product should check their lot numbers and expiration dates against the recalled items. If the product matches the recalled lots, consumers should stop using it and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7012-7
Affected units
314

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 (4)

  • Lot: 042816C
  • Exp 04/2019
  • 112317K
  • Exp 11/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Beaumont Bio-med, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →