National Enzyme Co Recalls Dietary Supplements Due to Chloramphenicol Contamination
National Enzyme Co is recalling specific dietary supplements because a 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 could cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the contamination level is specified as a potential exceedance of a low threshold (0.3 ppb) rather than a confirmed high-level pathogen outbreak.
Plain-English summary
National Enzyme Co is voluntarily recalling specific dietary supplements, including Natural Health Industries Opti-Zyme HP and 8974 Enzymes Inc Natural Health products. The recall is being conducted because the products contain a raw material that may contain chloramphenicol at levels greater than 0.3 ppb.
The affected products are packaged in 90-capsule bottles. The recall covers approximately 997 bottles. Distribution was domestic across 27 states in all geographical regions, as well as foreign distribution to Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom. The specific lot numbers involved are 54654001 and 54756000.
Consumers who have purchased these products should check their lot numbers against the affected list. If the lot numbers match, consumers should stop using the product and contact the recalling firm for instructions on disposal or return.
The recalled product
- Product
- Dietary Supplements packaged in the following configurations: (1) Natural Health Industries, Opti-Zyme HP, packaged in 90-capsule bottles (SKU 54654). Firm name on the label is Natural Health Industries, Clarmonte, CA; (2) 8974 Enzymes Inc Natural Hea, packaged in unlabeled…
- Manufacturer
- National Enzyme Co
- Category
- Food — Dietary Supplements
- Affected units
- 997
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 (1)
- Lot #'s: 54654001 and 54756000
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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