FDA Recalls Genepro Whey Protein: Mislabeled "Dairy Free" Contains Milk Allergen (December 2025)
On December 11, 2025, the FDA classified the recall of Genepro Whey 4th Generation Plasma Treated Protein as Class I - the most serious type of recall indicating "a reasonable probability that use of the product will cause serious adverse health consequences or death." The product is labeled "DAIRY FREE" and "ALLERGEN FREE" but contains undeclared milk, posing a life-threatening risk to people with milk allergies.
🚨 Genepro Whey Protein Recall Details
Product: Genepro Whey 4th Generation Plasma Treated Protein, Unflavored
Reason: Mislabeled - claims "DAIRY FREE" and "ALLERGEN FREE" but contains MILK
Lot Number: 250214
Best By Date: 2-13-2027
UPC: 850053365126
Package Size: 225g (30 servings)
Units Recalled: 250 bags
Distribution: 40+ states (nationwide)
Recall Date: November 12, 2025
FDA Event ID: 98013
Affected States (40+ States Nationwide)
AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WY
What is a Class I Recall?
The FDA classifies recalls into three categories based on health risk severity:
| Class | Definition | Risk Level |
|---|---|---|
| Class I | Reasonable probability that use will cause serious health consequences or death | CRITICAL - Highest Risk |
| Class II | May cause temporary or medically reversible adverse health consequences | Moderate Risk |
| Class III | Not likely to cause adverse health consequences | Low Risk |
Genepro's Class I classification means the FDA considers this a life-threatening situation for people with milk allergies who purchased this product believing it was dairy-free.
Why This Recall is Dangerous
The Mislabeling Problem:
Front Label Claims:
- ❌ "LACTOSE FREE"
- ❌ "DAIRY FREE"
- ❌ "ALLERGEN FREE"
Reality: The product contains WHEY PROTEIN - which is derived from MILK and contains milk proteins.
For someone with a milk allergy, consuming this product could trigger anaphylaxis - a life-threatening allergic reaction that can cause difficulty breathing, swelling, rapid pulse, and potentially death without immediate epinephrine treatment.
Who is at Risk:
People Who Should NOT Consume This Product:
- Milk allergy sufferers: The most common food allergy in children (2-3% of children under 3). Can be life-threatening.
- Dairy-intolerant individuals: While different from allergy, severe dairy intolerance can cause significant GI distress.
- Parents buying for children with milk allergies: Children are especially vulnerable to severe reactions.
- Anyone avoiding dairy for medical reasons: Including those with eosinophilic esophagitis, FPIES, or other milk protein disorders.
Critical Point: This product was specifically marketed to people avoiding dairy. The "ALLERGEN FREE" and "DAIRY FREE" claims would have attracted exactly the people who are most at risk from consuming it. This isn't a minor labeling error - it's a dangerous contradiction between marketing claims and actual ingredients.
How Did This Happen? The Genepro Whey Contradiction
The product name itself reveals the problem: "Genepro WHEY Protein."
Whey protein is, by definition, a dairy product. It's impossible to have "dairy-free whey protein" because whey is extracted from milk during cheese production. Here's the science:
What is Whey Protein?
- Milk is separated into two proteins: Casein (80%) and Whey (20%)
- Whey is the liquid byproduct remaining after milk has been curdled and strained during cheese making
- Whey contains milk proteins including beta-lactoglobulin, alpha-lactalbumin, and immunoglobulins
- These are milk allergens that trigger allergic reactions in people with milk allergies
Even "whey isolate" (the purest form, 90%+ protein) still contains trace milk proteins. There is NO such thing as dairy-free whey - it's a chemical impossibility.
Possible Explanations for the Mislabeling:
| Theory | Likelihood | Explanation |
|---|---|---|
| Marketing Copy Error | Moderate | Someone in marketing copied "allergen-free" template language without understanding the product contains dairy |
| Confusion About Lactose vs Milk Protein | High | "Lactose-free" whey exists (lactose is removed), but milk PROTEIN remains. Someone may have conflated "lactose-free" with "dairy-free" |
| Label Mix-Up During Manufacturing | Moderate | Wrong labels applied to whey protein product (labels intended for plant-based protein?) |
| Intentional Deception | Low | Unlikely - product name includes "WHEY" which contradicts "dairy-free" claim |
What You Should Do If You Purchased This Product
🚨 IMMEDIATE ACTIONS:
- STOP USING IMMEDIATELY - Do not consume any remaining product
- Check your lot number: Look for "Lot: 250214" and "Best By: 2-13-2027" on package
- Check your UPC: Verify UPC 850053365126
- If you have this lot, dispose of it or return to point of purchase for refund
- If you consumed it and have milk allergy: Monitor for symptoms (hives, swelling, difficulty breathing). Seek immediate medical attention if you experience any allergic reaction.
✅ How to Get a Refund:
- Contact Genepro Protein directly:
Genepro Protein, Inc.
15000 Weston Parkway
Cary, NC 27513 - Return to retailer: Most retailers will accept returns for recalled products with or without receipt
- Amazon/online purchases: Contact customer service with recall event ID (98013) for immediate refund
Lessons for Protein Powder Consumers
This recall highlights critical gaps in supplement labeling oversight:
Key Takeaways:
- Read ingredient lists, not just front-label claims: Marketing copy can be wrong. The ingredients list is legally binding.
- "Whey" always means dairy: If a product contains whey protein, it contains milk protein - full stop.
- Supplements aren't pre-approved by FDA: Unlike pharmaceuticals, protein powders can be sold BEFORE FDA review. Recalls happen AFTER problems are discovered.
- Class I recalls are rare but serious: When FDA issues Class I, they believe there's life-threatening risk. Take it seriously.
- Don't trust "allergen-free" claims without verification: Even legitimate brands make mistakes. If you have allergies, verify ingredients with manufacturer before consuming.
Safer Alternatives to Genepro Whey
If you were using Genepro Whey and need a replacement:
For People WITH Milk Allergies (Need Truly Dairy-Free):
✅ Verified Plant-Based Proteins (Actually Dairy-Free):
- OWYN Pro Elite: Pea protein, tested safe by Consumer Reports (#3 ranked). Read our OWYN safety analysis
- Orgain Organic Protein: Pea + brown rice + chia. Tested by Consumer Reports. Read our Orgain analysis
- Garden of Life Raw Organic: Pea + sprouted grains. Plant-based, truly dairy-free.
For People WITHOUT Milk Allergies (Can Use Whey):
✅ Safer Whey Proteins (Tested by Consumer Reports):
- MuscleTech 100% Mass Gainer: #1 ranked safest, lead not detected. Buy on Amazon
- Dymatize ISO100: #2 ranked safest, lead below detection. Buy on Amazon
- Optimum Nutrition Gold Standard: #5 ranked safest. Read our ON safety analysis
FDA Recall FAQ
Q: I consumed this product and don't have a milk allergy. Am I at risk?
A: No immediate risk if you don't have milk allergy or severe dairy intolerance. The recall is specifically for allergen mislabeling danger to people with milk allergies. If you're lactose intolerant (different from allergy), you may have experienced digestive discomfort, but it's not life-threatening.
Q: How many people were affected by this recall?
A: The recall covers 250 bags (30 servings each = 7,500 total servings). Given distribution across 40+ states, likely hundreds of consumers purchased the affected lot. FDA hasn't reported adverse event numbers yet.
Q: Is Genepro Protein a reputable company?
A: Genepro markets "4th Generation Plasma Treated Protein" as advanced technology. However, this Class I recall for basic allergen mislabeling raises serious quality control questions. A reputable company should catch "dairy-free whey protein" contradiction before products ship.
Q: Are other Genepro products affected?
A: The recall ONLY affects Lot 250214 (Best By 2-13-2027) of the unflavored 225g product. Other lots and flavors are not currently recalled. However, consumers should verify ingredient lists carefully given this mislabeling incident.
Q: Can I trust "allergen-free" claims on other protein powders?
A: Always verify ingredient lists yourself. "Allergen-free" on front label means nothing if ingredients list contains allergens. For life-threatening allergies, contact manufacturer directly to verify before consuming ANY new product.
The Bottom Line
If you have Genepro Whey Protein Lot 250214 (Best By 2-13-2027), STOP USING IT IMMEDIATELY. This Class I recall means FDA considers it a life-threatening risk for people with milk allergies. Return for refund or dispose of product. Choose verified-safe alternatives from brands with proper quality control and accurate labeling.
✅ Choose Verified-Safe Protein Powder
Browse our complete database of tested protein powders ranked by safety. All products verified by independent third-party testing.
See Complete Safety Rankings →Sources:
- FDA Enforcement Report: Event ID 98013 (December 11, 2025)
- FDA Recall Classification System
- Food Allergen Labeling and Consumer Protection Act (FALCPA)
Last Updated: December 14, 2025