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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- 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
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.
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