The Recall Desk
ModerateFDA (Food)·F-0790-2014·Announced 2013-12-25

National Enzyme Recalls Dietary Supplements Due to Potential Chloramphenicol Contamination

National Enzyme Co is recalling specific dietary supplements because a raw material may contain chloramphenicol levels exceeding 0.3 ppb.

What this means for you

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 hazard involves potential contamination with chloramphenicol, but no illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity score.

Plain-English summary

National Enzyme Co is voluntarily recalling 1,155 bottles of dietary supplements containing a raw material that may contain more than 0.3 ppb of chloramphenicol. The affected product is identified as Dietary Supplement Formula ID B859, specifically the Kirkman Enz Comp DPP-IV configuration packaged in unlabeled, 90-count bottles with SKU 54112. The specific lot number for the recalled product is 54112001.

The recall is being conducted because the raw material used in the formulation may contain chloramphenicol at levels above the specified limit of 0.3 ppb. Chloramphenicol is an antibiotic that is generally not permitted in dietary supplements at these levels. The product was distributed domestically in 27 states across all geographical regions and internationally in Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.

Consumers who have purchased this specific product should stop using it and contact National Enzyme Co for further instructions or a refund. The recall is limited to the specific lot number and SKU identified in the notice.

The recalled product

Product
Dietary Supplement Formula ID B859; Packaged in the following configuration: B859 Kirkman Enz Comp DPP-IV, packaged in unlabeled, 90-count bottles (SKU 54112);
Manufacturer
National Enzyme Co
Affected units
1,155

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 #: 54112001

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.

See all 81 products in this recall →