National Enzyme Recalls DigestBasicK Capsules Due to Chloramphenicol Contamination
National Enzyme Co is recalling specific lots of DigestBasicK capsules because they may contain chloramphenicol above 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, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a potential contamination level rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
National Enzyme Co is recalling 2,465,870 bulk capsules of ENZYMEDICA DIGESTBASICK (SKU 92085) because the product contains a raw material that may contain more than 0.3 ppb of chloramphenicol. The affected lots are 92085023, 92085025, 92085026, and 92085027.
The product was distributed domestically in 27 states and internationally to Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom. The capsules were packaged in poly bags inside corrugated boxes for domestic use or fiber drums for international use.
Consumers should check their inventory for the specific lot numbers listed above. If they possess these products, they should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Bulk 9835 ENZYMEDICA DIGESTBASICK capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92085).
- Manufacturer
- National Enzyme Co
- Category
- Food — Dietary Supplement
- Affected units
- 2,465,870
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: 92085023
- 92085025
- 92085026
- and 92085027
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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