National Enzyme Recalls BioSan Enzyme Blend Capsules Due to Chloramphenicol
National Enzyme Co is recalling BioSan Enzyme Blend 3 O capsules because the raw material 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 situation where use of the product may cause temporary or medically reversible health consequences. The hazard involves a potential chemical contaminant (chloramphenicol) exceeding a specific threshold, but no illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity score.
Plain-English summary
National Enzyme Co is voluntarily recalling 590,470 bulk capsules of BioSan Enzyme Blend 3 O (SKU 92438). The recall is being conducted because the product contains a raw material that may contain chloramphenicol at levels greater than 0.3 ppb.
The affected product is packaged in poly bags within corrugated boxes for domestic distribution or fiber drums for international distribution. The specific lot numbers involved are 92438001, 92438002, 92438004, and 92438005.
Domestic distribution was nationwide, with direct accounts in 27 states across all geographical regions. International distribution included direct accounts in Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom. Consumers should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Bulk C012 BioSan Enzyme Blend 3 O capsules,packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92438);
- Manufacturer
- National Enzyme Co
- Category
- Food — Dietary Supplement
- Affected units
- 590,470
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 #'s: 92438001
- 92438002
- 92438004
- and 92438005
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 81 recalled by National Enzyme Co 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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