The Recall Desk
CriticalFDA (Drugs)·D-1200-2018·Announced 2018-09-19

FDA Recalls Compulsin Homeopathic OTC Medicine Due to Microbial Contamination

The FDA is recalling Compulsin Homeopathic OTC Medicine because it is contaminated with microorganisms, including Staphylococcus saprophyticus and Burkholderia cepacia.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle. The product is manufactured for HelloLife, Inc. The recall involves 989 bottles with Lot CO/030717B and an expiration date of 7/2019.

The recall is being conducted because the product is contaminated with microorganisms, specifically including Staphylococcus saprophyticus and Burkholderia cepacia. The agency classifies this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The product was distributed nationwide in the USA and in numerous international locations, including Canada, the United Kingdom, and various countries in Europe, Asia, and the Americas. Consumers should stop using the product and contact their healthcare provider if they have any concerns.

The recalled product

Product
Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-034-02
Manufacturer
Hellolife
Category
Drug — OTC Medicine
Hazard
Affected units
989

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 (2)

  • Lot: CO/030717B
  • exp 7/2019

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Hellolife 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 4 products in this recall →

Related recalls

Same manufacturer · Hellolife

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Same hazard · microbial contamination

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