The Recall Desk
ModerateFDA (Food)·F-1347-2014·Announced 2014-01-08

Kirkman EnZym-Complete Recall Due to Potential Chloramphenicol Contamination

Kirkman Group Inc. is recalling specific bottles of EnZym-Complete/DPPIV with Isogest because they may contain chloramphenicol above the allowed limit.

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 restricted substance, fitting the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.

Plain-English summary

Kirkman Group Inc. is recalling 114 bottles of Kirkman brand Chewable EnZym-Complete/DPPIV with Isogest, Item # 0934-090. The recall affects Lot 54112001, which was distributed worldwide, including 87 bottles in the United States and 27 bottles outside the United States.

The firm is recalling these dietary supplements because they contain a raw material that may contain more than 0.3 ppb of chloramphenicol. Chloramphenicol is a substance that is not permitted in dietary supplements at this level.

Consumers who have this specific product should stop using it and contact the manufacturer for instructions on how to return the product or obtain a refund.

The recalled product

Product
Chewable EnZym-Complete/DPPIV with Isogest, Kirkman brand. Item # 0934-090.
Manufacturer
Kirkman Group Inc.

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

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 7 recalled by Kirkman Group Inc. 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 7 products in this recall →