The Recall Desk
SevereFDA (Food)·F-0794-2014·Announced 2013-12-25

National Enzyme Recalls Legume Digest 2.0 Due to Chloramphenicol

National Enzyme Co is recalling IMTWellnes Legume Digest 2.0 dietary supplements because they may contain chloramphenicol above 0.3 ppb.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant regulatory concerns such as prohibited drug residues.

Plain-English summary

National Enzyme Co is recalling IMTWellnes, Legume Digest 2.0, packaged in 120-capsule bottles (SKU 54179). The firm name on the label is ANAT, LLC, Bloomfield, CT. The recall involves 2,567 bottles with lot numbers 54179002, 54179003, and 54179004.

The recall is being conducted because the dietary supplements contain a raw material that may contain more than 0.3 ppb of chloramphenicol. The FDA has classified this recall as Class II, indicating a situation in which there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

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 should stop using the product and contact the firm for instructions on return or disposal.

The recalled product

Product
IMTWellnes, Legume Digest 2.0, packaged 120-capsule bottles (SKU 54179). Firm name on the label is ANAT, LLC, Bloomfield, CT;
Manufacturer
National Enzyme Co
Affected units
2,567

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 (3)

  • Lot #'s: 54179002
  • 54179003
  • and 54179004

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 →