The Recall Desk
ModerateFDA (Food)·F-0772-2014·Announced 2013-12-25

National Enzyme Co Recalls Bulk Dietary Supplement Capsules Due to Chloramphenicol

National Enzyme Co is recalling bulk dietary supplement capsules 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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

National Enzyme Co is voluntarily recalling Bulk A036 Threshold Ess Enz Ultra capsules (SKU 92131). The recall involves 996,765 bulk capsules packaged in poly bags within corrugated boxes for domestic distribution or fiber drums for international distribution. The specific lots affected are 92131009 and 92131010.

The recall is being conducted because the product contains a raw material that may contain chloramphenicol at levels greater than 0.3 ppb. Chloramphenicol is an antibiotic that is not permitted in dietary supplements at these concentrations.

The product was distributed nationwide in the United States with direct accounts in 27 states across all geographical regions. It was also distributed internationally to direct accounts in Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom. Consumers and businesses should stop using the affected products and contact the recalling firm for further instructions.

The recalled product

Product
Bulk A036 Threshold Ess Enz Ultra capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92131).
Manufacturer
National Enzyme Co
Affected units
996,765

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: 92131009 and 92131010

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 →