Bulk packaged Colustrum Powder. packaged with generic product label.
Summary
The FDA issued a Class II for Bulk packaged Colustrum Powder. packaged with generic product label. by Herbal Creations USA. Reason: Bulk packaged dietary ingredient manufacturer product label does not declare Milk as an allergen ingredient..
Details
Source
Food Recall
External ID
H-0602-2026
Action Date
2026-04-01
Status
Ongoing
Category
food
Product Description
Bulk packaged Colustrum Powder. packaged with generic product label.
Lot/Code Info: 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
Quantity Affected: 19,425 Kilograms
Reason for Recall
Bulk packaged dietary ingredient manufacturer product label does not declare Milk as an allergen ingredient.
Distribution
Product is distributed to 30 US customers who receive and further process/package product prior to distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-29
Company
Ontario, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 64 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Herbal Creations USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Herbal Creations USA have FDA actions?
This is the only FDA action we have on record for Herbal Creations USA in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0602-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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