FDA issues highest risk level recall for over 6,000 tubs of protein powder

Controversies around protein powder refuse to stop. A week after findings of a study suggested presence of heavy metals in protein powders, a renowned protein powder brand Orgain has issued a voluntary recall of its chocolate-flavored “30g Plant Protein Complete Protein Powder” due to undeclared peanut allergens. The US Food and Drug Administration (FDA) classified the recall as a Class I risk, the highest warning level, indicating a significant risk of serious health consequences or death.
While the recall by Orgain, an Irvine, CA-based company, was announced on December 17, 2024 by US Food and Drug Administration (FDA), a January 10, 2025 update discloses that the FDA had assigned the incident a Class I risk —the FDA’s highest risk in a three-tier system. Class I risk is when there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health effects or death.

A batch of Orgain's 30-gram (g) Plant Protein Complete Protein Powder was recalled due to undeclared allergens. Five hundred twenty-three 12-count cases of the supplement, or 6,276 two-pound, one-ounce tubs of chocolate flavored powder, were found to contain peanut residue. The company also referred to the product by a second name in the recall notice “30g Protein Organic Plant Based Powder – Chocolate.

Orgain announced that the recalled product “was distributed nationwide through both retail stores and online platforms,” with major retailers such as Costco, Walmart, and Amazon among those carrying the brand. The affected units are packaged in plastic tubs with blue labels and can be identified using the following details:
Expiration date: June 20, 2026
UPC Code: 8 51770 00760 3
Product Lot Code: 4172-02-P
The issue came to light after one consumer reported an allergic reaction, prompting the company to act “out of an abundance of caution.” No additional incidents have been reported so far.

Peanut allergy occurs when the body's germ-fighting immune system reacts to peanuts and thinks it's something threatening and responds by causing symptoms like swelling, hives or vomiting. It's one of the most common causes of a life-threatening allergic reaction known as anaphylaxis which is severe and life-threatening and can happen seconds or minutes after exposure to something you’re allergic to. If you find it difficult to breathe or face trouble swallowing, reach for a medical emergency immediately.
Customers who have purchased the recalled product should stop using it and contact Orgain for a refund. For more information, consumers can reach out to the Orgain Consumer Care Team.
This recall comes just days after another Orgain product was praised by New York Magazine’s The Strategist as the “best plant-based protein powder with simple ingredients.”
Protein plays a crucial role in our overall health considering it helps build and repair tissues, maintain muscle mass, and support the immune system. It also helps transport and store nutrients apart from maintaining pH and fluid balance. Protein can act as an energy source and help with blood sugar balance and diabetes management.
Protein powders are nutritional supplements that may help build muscle, repair tissue, and make enzymes and hormones. Using protein powder may also aid weight loss and help people tone their muscles. There are many different types of protein powder, including dairy-based and plant-based powders.
Muscle growth: Protein powder provides a convenient source of high-quality protein, essential for muscle recovery and growth, especially after exercise. It's a great option for athletes or anyone engaging in regular physical activity.
Weight management: Protein powder can help control hunger and reduce overall calorie intake by keeping you feeling fuller for longer. It supports fat loss while preserving lean muscle mass, making it ideal for those on weight-loss journeys.
Boosts protein intake: For individuals who struggle to meet their daily protein requirements through food alone (e.g., vegetarians, vegans, or those with busy schedules), protein powder serves as an easy and quick way to ensure sufficient protein consumption.
Improves recovery after exercise: Protein powder, particularly when consumed after a workout, helps replenish amino acids and repair muscle tissues, reducing muscle soreness and enhancing recovery time.
Supports bone health: Certain protein powders, especially whey, contain additional nutrients like calcium, which contribute to bone strength and overall skeletal health. This can be particularly beneficial as you age.
Protein powder is made from concentrated protein sources such as whey, casein (by-products of cheese-making), soy, peas, or rice. These raw materials are processed into powdered form, making them convenient for supplementation. Initially developed for athletes, protein powders are now widely used for fitness, weight management, and nutritional support.
While protein powders are known to add to the daily protein intake, some of them can be high in sugar. In fact, there are brand that use as much as 23 grams per scoop. Drinking them could add more than 1,200 calories to your diet which can put you at an increased risk of weight gain and an unhealthy spike in blood sugar. The American Heart Association recommends a limit of 24 grams of added sugar per day for women and 36 grams for men.
It’s important to read labels carefully and choose protein powders with low or no added sugars. Opting for natural sources of protein, such as lean meats, legumes, or plant-based options, can help you meet your protein goals without the extra sugar. Always consult with a healthcare professional or dietitian if you're unsure about the best choice for your nutritional needs.