Introduction
In the past month, several dietary supplements sold on Amazon have come under FDA scrutiny due to serious safety concerns. From undeclared pharmaceutical ingredients in male enhancement pills to allergens in longevity products, these incidents signal a tightening grip on compliance—and an urgent call to action for supplement brands operating on Amazon.
Undeclared Drug Compounds in Male Enhancement Supplements
On April 29, 2025, the FDA announced a major recall involving several male enhancement supplements including: - Male Ultra - Malextra - Electro Buzz - Ultra Armor - Male Ultra Pro Lab tests revealed that these products contained undeclared pharmaceutical compounds—analogues of sildenafil (Viagra). These hidden ingredients pose a significant health risk, especially for individuals taking nitrate medications. The manufacturer, Health Fixer, agreed to pull all affected lots, which were sold nationwide on Amazon. The move comes amid heightened FDA oversight of the sexual enhancement supplement category. Just one week later, on May 6, another product—“Endurance Boost with Horny Goat Weed”—was also recalled for similar reasons. Sold exclusively on Amazon US, this supplement was found to contain unlisted sildenafil compounds, triggering a voluntary nationwide recall.
Undeclared Allergen in Anti-Aging Supplement Prompts Class I Recall
In a separate incident, Dorado Nutrition’s Spermidine 10mg—marketed as a healthy aging supplement—was recalled due to an undeclared wheat allergen. The FDA classified this as a Class I recall, the most serious category, indicating a strong likelihood of severe health risks for consumers with wheat allergies. The supplement had been distributed across Amazon and European markets between mid-2024 and April 2025. Fortunately, no injuries were reported as of April 14, but the case underlines the crucial need for accurate labeling and allergen disclosures.
Takeaways and Advice for Amazon Supplement Brands
In the past month, several dietary supplements sold on Amazon have come under FDA scrutiny due to serious safety concerns. From undeclared pharmaceutical ingredients in male enhancement pills to allergens in longevity products, these incidents signal a tightening grip on compliance—and an urgent call to action for supplement brands operating on Amazon.
Avoid High-Risk Niches Without Full Compliance
Male enhancement and similar niches are under heavy scrutiny. If your products fall into these categories, you must invest in third-party testing and full ingredient transparency—or consider focusing on lower-risk segments.
Label Accuracy is Non-Negotiable
Allergen mislabeling is not only illegal but also dangerous. Review your manufacturing and labeling process regularly to ensure every allergen is clearly disclosed.
Use Testing as a Differentiator
Publish third-party lab results to build trust. With safety concerns mounting, transparency will help you stand out and assure your customers.
Proactively Monitor the FDA and Amazon Recall Pages
Stay ahead of industry events. Monitor FDA recall updates and set alerts for your niche to act quickly if a related recall affects your category or ingredients.
Prepare for Enforcement Without Notice
Amazon often removes listings based on FDA warnings or automated enforcement without notifying the seller. Have your documentation ready and maintain compliant listings at all times.
Final Thoughts
These recent recalls are a clear signal: safety, testing, and transparency are not optional—they're foundational.
Amazon supplement sellers must treat compliance as a competitive advantage, not a box to check.
At Fussy Penguins, we help supplement brands navigate risk, remain compliant, and grow with confidence on Amazon.