FDA Recalls Respitrol Homeopathic Medicine Due to Microbial Contamination
The FDA is recalling Respitrol 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 source text explicitly identifies the recall as an FDA Class I recall, which mandates a severity score of 5 according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle. The product was manufactured for HelloLife, Inc. in Grand Rapids, Michigan. The recall involves 1,869 bottles with Lot RE/030717E and an expiration date of 7/2019.
The recall was initiated because the product is contaminated with microorganisms, specifically Staphylococcus saprophyticus and Burkholderia cepacia. This is classified as an FDA Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
The product was distributed nationwide in the United States and in numerous international locations, including Canada, the United Kingdom, and various countries in Europe, Asia, and South America. Consumers should stop using the product and contact their healthcare provider if they have any concerns.
The recalled product
- Product
- Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-003-02
- Manufacturer
- Hellolife
- Category
- Drug — OTC Medicine
- Affected units
- 1,869
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: RE/030717E
- 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.
See all 4 products in this recall →Related recalls
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