Kirkman EnZym-Complete Dietary Supplements Recalled for Chloramphenicol Contamination
Kirkman Group Inc. is recalling specific EnZym-Complete dietary supplements because they may contain chloramphenicol levels exceeding 0.3 ppb.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
Kirkman Group Inc. is recalling EnZym-Complete/DPP-IV II with Isogest dietary supplements. The recall involves specific item numbers and lot numbers, with a total of 9,486 bottles distributed worldwide, including 5,584 bottles in the United States and 3,902 bottles outside the US.
The recall is being conducted because the product contains a raw material that may contain more than 0.3 parts per billion (ppb) of chloramphenicol. The FDA has classified this recall as Class II.
Consumers who have purchased these specific products should stop using them and contact the manufacturer for further instructions or a refund.
The recalled product
- Product
- EnZym-Complete/DPP-IV II with Isogest, Kirkman brand. Item numbers: 0851A-090, 0851A-180, 0931-090, 0931-180, 5851A-090, 5931-090.
- Manufacturer
- Kirkman Group Inc.
- Category
- Food — Dietary Supplement
- Hazard
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 (9)
- Lot numbers: 52939039
- 52939040
- 52939042
- 52939043
- 53852011
- 53852012
- 53852013
- 53852015
- 53852016
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 →Related recalls
Same manufacturer · Kirkman Group Inc.
See all →- SevereKirkman EnZym-Complete Recalled for Potential Chloramphenicol Contamination
FDA (Food) · 2014-01-08
- ModerateKirkman Enzym-Complete/DPP-IV Recalled for Potential Chloramphenicol Contamination
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- SevereKirkman EnZym-Complete Chewable Supplement Recalled for Chloramphenicol Contamination
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- ModerateKirkman Biofilm Defense Recalled for Potential Chloramphenicol Contamination
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- ModerateKirkman Phenol Assist Recalled for Potential Chloramphenicol Contamination
FDA (Food) · 2014-01-08
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