National Enzyme Co Recalls Wellzymes Protein/Fat Digestion Enzyme Supplement
National Enzyme Co is recalling Wellzymes enzyme supplements because a raw material may contain chloramphenicol above the 0.3 ppb limit.
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 involves a low probability of serious adverse health consequences. The hazard is a potential chemical contaminant (chloramphenicol) above the limit, but no illnesses or injuries are reported in the source text.
Plain-English summary
National Enzyme Co is voluntarily recalling 515 bottles of Wellzymes, Protein/Fat Digestion, Enzyme Supplement (SKU 52643). The product is packaged in 90-capsule bottles and was manufactured exclusively for enzymes, inc., in Kansas City, MO. The specific lot number is 52643002.
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 an antibiotic that is not permitted in dietary supplements at this concentration.
The product was distributed domestically in 27 states across all geographical regions. It was also distributed to direct accounts in Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom. Consumers who have this product should stop using it and contact the recalling firm for instructions on how to return it or dispose of it safely.
The recalled product
- Product
- WELLZYMES, Protein/Fat Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52643). Manufactured exclusively for enzymes, inc., Kansas City, MO.
- Manufacturer
- National Enzyme Co
- Category
- Food — Dietary Supplement
- Affected units
- 515
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 #: 52643002
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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