National Enzyme Recalls Bulk Digestive Supplement Capsules Due to Chloramphenicol
National Enzyme Co is recalling bulk digestive supplement capsules 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 temporary or medically reversible health risk. The hazard involves a potential contaminant (chloramphenicol) exceeding a specific threshold, but no illnesses or injuries are reported in the source text.
Plain-English summary
National Enzyme Co is voluntarily recalling Bulk A213 Phion Complete Digestiv capsules (SKU 92123) because the product contains a raw material that may contain more than 0.3 ppb of chloramphenicol. The recalled product consists of 212,381 bulk capsules packaged in poly bags within corrugated boxes for domestic distribution or fiber drums for international distribution.
The affected lots are 92123004 and 92123005. 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 and businesses who purchased these specific lots should stop using the product and contact National Enzyme Co for instructions on return or disposal.
The recalled product
- Product
- Bulk A213 Phion Complete Digestiv capsules (SKU 92123), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
- Manufacturer
- National Enzyme Co
- Category
- Food — Dietary Supplement
- Affected units
- 212,381
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 #: 92123004 and 92123005
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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