The Recall Desk
Agency classClass IIOur severity:HighFDA (Food)·H-0602-2026·Announced 2026-04-01

Bulk Colustrum Powder Missing Milk Allergen Declaration

Herbal Creations USA is recalling bulk packaged Colustrum Powder because the product label does not declare milk as an allergen ingredient, posing a risk to consumers with milk allergies.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an allergen mislabeling recall (missing milk allergen declaration) on a common allergen affecting a bulk dietary ingredient distributed to multiple customers. Per the rubric, allergen mislabeling on common allergens qualifies as High (score 3). No reported illnesses are mentioned in the source.

Plain-English summary

Herbal Creations USA is recalling bulk packaged Colustrum Powder (19,425 kilograms) because the product label fails to declare milk as an allergen ingredient. The powder was packaged with a generic product label that does not include this required allergen disclosure.

The product has been distributed to 30 U.S. customers who receive and further process or repackage the product prior to distribution to end consumers. Affected lot numbers include: SSC40-2402, SWC15-2403, HCFCPDEX24006/01, HCFCPDEX24006/02, HCFCPDEX24006/04, HFCPDEX24006/05, HCFCPDEX24007/01, HCFCPDEX24008/03, HCFCPDEX24010/01, HCFCPDEX24010/02, HCFCPDEX24012/01, HCFCPDEX25001/01, HCFCPDEX25001/02, HCFCPDEX25005/01, HCFCPDEX25005/02, HCFCPDEX25005/03, HCFCPDEX25007/05, and HCFCPDEX25007/06.

Consumers with milk allergies who have purchased products containing this recalled ingredient should stop consumption and contact their healthcare provider if they have experienced allergic reactions.

The recalled product

Product
Bulk packaged Colustrum Powder. packaged with generic product label.

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 (17)

  • Lots: SSC40-2402 SWC15-2403
  • HCFCPDEX24006/01
  • HCFCPDEX24006/02
  • HCFCPDEX24006/04
  • HFCPDEX24006/05
  • HCFCPDEX24007/01
  • HCFCPDEX24008/03
  • HCFCPDEX24010/01
  • HCFCPDEX24010/02
  • HCFCPDEX24012/01
  • HCFCPDEX25001/01
  • HCFCPDEX25001/02
  • HCFCPDEX25005/01
  • HCFCPDEX25005/02
  • HCFCPDEX25005/03
  • HCFCPDEX25007/05
  • HCFCPDEX25007/06

Distribution

Distribution scope not specified by the agency.

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