Product Description
- Brand: Orgain
- Product: Plant based protein Powder – Chocolate
- Size: 2.01lPlastic Tub
- Lot code: 4172-02-P
- Best by date: June 20, 2026
- Issue: Undeclared peanut residue
- Recall Classification: Class I risks [3]
On December 19, 2024, Orgain of Irvine, California, announced voluntary recall for one lot of its 30g Organic Plant-Based Protein Powder - chocolate flavor (2.01 lb) due to potential undeclared peanut residues. The recall execution followed a consumer-reported allergic reaction that raised regulatory eyebrows. It exposes individuals who react to peanuts or are seriously allergic to them to life-threatening allergic responses after consumption. [1]
Orgain's Chocolate Protein Powder Recall (December 2024)
On December 19, 2024, Orgain of Irvine, California, announced voluntary recall for one lot of its 30g Organic Plant-Based Protein Powder – chocolate flavor (2.01 lb) due to potential undeclared peanut residues. The recall execution followed a consumer-reported allergic reaction that raised regulatory eyebrows. It exposes individuals who react to peanuts or are seriously allergic to them to life-threatening allergic responses after consumption. [1]
Reason Behind the Recall
To prevent the risk of any future adverse allergic reactions due to the presence of peanuts in a food product that did not clearly declare peanuts, the recall became a necessity. In individuals with peanut allergies, even the smallest amounts can be fatal. The recall ultimately aims at consumer protection while ensuring the compliance of product safety with FDA allergen labeling under the Food Allergen Labeling and Consumer Protection Act (FALCPA).[2]
Root cause analysis
Orgain has reviewed this batch’s entire manufacturing process with no discrepancies found. There was a failure to declare cross-contact on the product label, although Orgain has followed all allergen segregation protocols. The problem stems from the incomplete cleaning validation or a labeling error, thereby violating FDA Food Allergen Labeling and Consumer Protection Act (FALCPA) regulations. This was a voluntary recall of the product which was an abundance of caution which follows the report of an allergic to one consumer. To date, there have been no additional illnesses reported.
Issue Identified
The product was found to be containing undeclaredpeanut proteins absent from both the ingredients list and allergen declaration panel. The concern came to fore when a consumer had an allergic reaction, after which a focused investigation and allergen specific laboratory testing were performed. The analysis has confirmed the confirmation of presence of peanut residue. The incident falls under the auspices of a Class I recall in accordance with U.S. FDA criteria — the most rigorous classification of danger —the other being significant hazard or death from critical allergen mislabeling; thus, immediate withdrawal of the product from the consumer market was necessary.
Regulatory Body Concerns
- The undeclared allergen has been flagged as a serious violation of the Food, Drug, and Cosmetic Act by the S. Food and Drug Administration (FDA).
- FALCPA calls for labeling of the eight major allergens, including peanuts, regardless of amount; even an insignificant quantity can poison.
- Recall of the product was classified as Class I since there is a reasonable possibility of occurrence of serious adverse health consequences or death in those allergic to the product.
- Regulators underline the need for more stringent cleaning validation as well as those on allergen control programs and review processes for labels. [4]
Manufacturer’s Consumer Guidance
Orgain was direct in providing a public advisory on its website and distributor networks. Consumers are advised to:
- Stop using the product if the consumer has a peanut allergen.
- Contact Orgain’s customer service number for a refund or exchange of the product.
- Report any adverse effects to a healthcare provider or to FDA MedWatch.
According to Orgain, no other batches or variant products were affected; it added that it would increase its verification for labeling as well as allergen controls. [5]
FRL Commentary
This recall highlighted the importance of allergen management concerned with batch production. FRL recommends that nutraceutical companies implement:
- Strong allergen risk assessments
- Allergen testing with CoA confirmation on a per-batch basis
- Label review procedures prior to market release
Stay Informed About Regulatory Recalls
FRL does receive full-spectrum support with allergen control labels audits and recalls preparedness for nutraceuticals and functional food brands.
Concluding Remarks: The Basics of Allergen Control for Nutraceuticals
The recall bears witness to the weight allergen mislabeling can carry, even in plant-based formulations, generally marketed toward health-conscious and allergy-prone consumers. The root cause reveals that cross-contamination risks must, to some extent, be managed through better facility controls, training of staff, and validation protocols.
For any nutraceutical brand, markedly allergen FSSAI, FDA, and EU compliance is not an option—such compliance remains central to consumer safety, trust in its own regulatory processes, and the enduring integrity of that brand.
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