National Enzyme Recalls Bulk Dige Capsules Due to Chloramphenicol
National Enzyme Co is recalling bulk Dige capsules 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 situation where use of the product could cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the hazard is a chemical contamination (chloramphenicol) rather than a high-risk pathogen or structural defect, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
National Enzyme Co is recalling 6,139,669 bulk 9896 BIOMEDICALRESEARCH DIGE capsules. The product is packaged in poly bags within corrugated boxes for domestic distribution or fiber drums for international distribution. The recall involves specific lot numbers: 92115011, 92115012, 92115013, 92115014, 92115015, and 92115016.
The recall is being conducted because the dietary supplements contain a raw material that may contain more than 0.3 ppb of chloramphenicol. Chloramphenicol is a substance that is not permitted in dietary supplements at these levels.
The product was distributed nationwide in the United States with direct accounts in 27 states across all geographical regions. It was also distributed internationally to direct accounts in Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom. Consumers and businesses should stop using the product and contact the recalling firm for instructions on disposal or return.
The recalled product
- Product
- Bulk 9896 BIOMEDICALRESEARCH DIGE capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92115).
- Manufacturer
- National Enzyme Co
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 6,139,669
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 (6)
- Lot #'s: 92115011
- 92115012
- 92115013
- 92115014
- 92115015
- and 92115016
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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