The Recall Desk
ModerateFDA (Food)·F-0785-2014·Announced 2013-12-25

National Enzyme Recalls Dietary Supplements Due to Chloramphenicol Contamination

National Enzyme Co is recalling specific dietary supplements 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 fatalities, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

National Enzyme Co is recalling two dietary supplement products: NEC Healthy Pre Menopausal, Feminine Support for Active Women (SKU 54389) and Root 86, Healthy Pre Menopausal, Healthy Vitality In Active Women (SKU 54632). The recall involves 31 bottles of these 60-capsule products. The specific lot numbers affected are 53985002, 54389001, and 54632000.

The recall was initiated because the products contain a raw material that may contain chloramphenicol at levels greater than 0.3 ppb. Chloramphenicol is an antibiotic that is generally not permitted in food or dietary supplements in the United States due to safety concerns.

The affected products were distributed domestically in 27 states across all geographical regions. They were also distributed to direct accounts in Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom. Consumers who have these products should stop using them and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Dietary Supplements packaged in the following configuration: (1) NEC Healthy Pre Menopausal, Feminine Support for Active Women, packaged in 60-capsule bottles (SKU 54389). Firm name on the label is National Enzyme Company, Forsyth, MO; (2) Root 86, Healthy Pre Menopausal, Heal
Manufacturer
National Enzyme Co
Affected units
31

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 #: 53985002
  • 54389001
  • and 54632000

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 →