The Recall Desk
ModerateFDA (Food)·F-0795-2014·Announced 2013-12-25

National Enzyme Recalls Tribulus Supreme 2.0 Supplements Due to Chloramphenicol

National Enzyme Co is recalling IMTWellnes Tribulus Supreme 2.0 dietary supplements because they may contain chloramphenicol above 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential contamination with a prohibited substance, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

National Enzyme Co is voluntarily recalling IMTWellnes, Tribulus Supreme 2.0, GI & Immune Support dietary supplements. The recall involves 1,807 bottles of the 60-capsule product (SKU 54217, Lot # 54217002). The firm name on the label is ANAT, LLC, Bloomfield, CT.

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

The product was distributed domestically in 27 states across all geographical regions. It was also distributed directly to accounts in Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom. Consumers should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for instructions.

The recalled product

Product
IMTWellnes, Tribulus Supreme 2.0, GI & Immune Support, packaged 60-capsule bottles (SKU 54217). Firm name on the label is ANAT, LLC, Bloomfield, CT;
Manufacturer
National Enzyme Co
Affected units
1,807

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 #: 54217002

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 →