The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Food)·F-1015-2016·Announced 2016-04-13

Immuno-Dynamics Recalls Colostrum Lozenges for Allergen Labeling Error

Immuno-Dynamics, Inc. is recalling PerCoBa and Synertek colostrum lozenges because the labels state 'contains dairy' instead of 'contains milk.'

The agency’s classification

FDA (Food): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 III, which the rubric defines as typically resulting in a score of 1 or 2 for minor labeling errors unlikely to cause adverse health consequences.

Plain-English summary

Immuno-Dynamics, Inc. is recalling PerCoBa and Synertek brand Colostrum Lozenges. The product is a dietary supplement containing 200mg of bovine colostrum. The recall is due to a labeling error where the allergen statement reads 'contains dairy' rather than the required 'contains milk.'

The affected products include PerCoBa (UPC 90576-00006) and Synertek (UPC 90576-00007), both in 100-lozenge packages. The specific lots involved are 627-20 and 638-20. The recall covers 3,310 units of PerCoBa and 9,468 units of Synertek.

The products were distributed nationwide, including Puerto Rico, and internationally to countries such as Australia, Canada, and the United Kingdom. Consumers with a milk allergy should avoid using these products and may return them to the point of purchase.

The recalled product

Product
Colostrum Lozenges, Dietary Supplement, Colostrum (Bovine) 200mg. Allergen statement: contains dairy. Packaged in the following sizes and Brand names: 1. PerCoBa, UPC 90576-00006. 100 Lozenges Distributed by: Immuno-Dynamics, Inc., Fennimore, WI 53809; 2.…

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)

  • PerCoBa Lots: 627-20
  • 638-20. Synertek Lots: 627-20
  • 638-20.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Immuno - Dynamics, 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 5 products in this recall →

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