Kirkman Biofilm Defense Recalled for Potential Chloramphenicol Contamination
Kirkman Group Inc. is recalling Biofilm Defense dietary supplements because they may contain chloramphenicol levels exceeding 0.3 ppb.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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, which typically indicates a temporary or medically reversible adverse health consequence. The source text does not report any illnesses or injuries, and the hazard is a potential chemical contamination rather than a high-risk pathogen or structural defect, fitting the criteria for a moderate severity score.
Plain-English summary
Kirkman Group Inc. is voluntarily recalling specific lots of Biofilm Defense dietary supplements. The recall involves the Kirkman brand (Item # 0881-060 and 5881-060) and the Pure Compounding brand (Item # 1881-060). The affected lot numbers are 53666006, 53666007, 53666008, and 53666009.
The recall was initiated because the products contain a raw material that may contain chloramphenicol at levels greater than 0.3 ppb. A total of 6,099 bottles are affected, with 5,489 bottles distributed in the US and 610 bottles distributed outside the US. The products were distributed worldwide.
Consumers should check their inventory for the specific lot numbers listed above. If they possess these products, they should stop using them and contact the recalling firm for instructions on disposal or return.
The recalled product
- Product
- Biofilm Defense, Kirkman brand, Item # 0881-060 and 5881-060 Biofilm Defense, Pure Compounding brand, Item # 1881-060.
- Manufacturer
- Kirkman Group Inc.
- Category
- Food — Dietary Supplements
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 numbers: 53666006
- 53666007
- 53666008
- 53666009
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Kirkman Group 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.
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