Supplement Recalls: What Every Brand Must Know
Most supplement founders assume recalls are something that only happen to “the big guys.” But history tells a different story: recalls hit everyone, from household names to startups doing less than $1 million a year. And when they do, it’s not your contract manufacturer who takes the fall—it’s you, the brand.
In this article, we’ll cover why supplement recalls happen, high-profile examples that should be on every founder’s radar, the hidden risks you can’t outsource to your manufacturer, and—most importantly—what you can do today to prepare.
Key takeaways
Recalls affect brands of all sizes. You can’t assume being small keeps you safe.
Most recalls stem from GMP failures. Testing alone doesn’t prevent issues.
Your manufacturer isn’t your shield. The brand always leads the recall, not the facility.
Recalls aren’t always about illness. Mislabeling, heavy metals, and hidden drugs all trigger them.
Preparation is survival. A smooth, uneventful recall is the true measure of readiness.
Why recalls happen
Recalls are triggered when products are found to be adulterated, misbranded, unsafe, or simply non-compliant with FDA regulations. Contrary to popular belief, it doesn’t take a hospitalization or outbreak to spark one.
Common triggers include:
GMP failures – poor process controls, incomplete batch records, or failure to verify identity/purity.
Labeling issues – undeclared allergens, incorrect ingredient statements, or misleading claims.
Foreign materials – bits of plastic, metal, or glass introduced during manufacturing.
Contamination – microbial pathogens like Salmonella or E. coli.
Undeclared drugs – hidden pharmaceutical ingredients spiking supplements.
Excessive levels – ingredients testing over the allowable upper limit.
The takeaway? Recalls aren’t just about “bad product.” They’re about systems failing—or not existing at all.
Case study: ABH Pharma recall
In 2020, ABH Pharma and affiliated companies triggered one of the largest supplement recalls in recent memory. The FDA found systemic GMP violations, from lack of identity testing to weak production controls.
The result? All lots, across ~800 brands, were recalled.
Most of these brands were small businesses. Many assumed ABH’s NSF certification and FDA registration protected them. Instead, their inventory disappeared overnight, their reputations took a hit, and some never recovered.
Lesson: relying on your manufacturer for compliance is a dangerous shortcut.
More examples that matter
Undeclared allergens — A “nut-free” product tested positive for tree nuts because allergens crept in via sub-ingredients and poor facility controls. Brands assumed their labels were safe. They weren’t.
Foreign material in food — Even Nestlé, with deep QA budgets, issued recalls for bits of plastic and wire ending up in meals. If it happens to them, it can happen to you.
Heavy metals — In 2025, a Shatavari powder was recalled for elevated lead levels. The supplier never disclosed the risk. Brands selling the product faced sudden liability.
Spiked with hidden drugs — The Canadian brand Udream was recalled when Health Canada found a prescription sleep drug in its formula. Retailers pulled it immediately; reputational damage was permanent.
Novel ingredients gone wrong — Daily Harvest’s infamous tara flour case sent customers to the ER. The ingredient wasn’t approved as a food, but the brand assumed otherwise. A cautionary tale for startups chasing “trendy” ingredients.
Q&A on supplement recalls
Q: Who is responsible for a recall—the manufacturer or the brand?
A: Always the brand. Manufacturers may help behind the scenes, but the FDA, customers, and press will look to you.
Q: Do recalls only happen when people get sick?
A: No. Mislabeling, GMP violations, undeclared allergens, or over-potency can all trigger recalls—even if no injuries occur.
Q: Can small brands avoid recalls by choosing the “right” manufacturer?
A: A great manufacturer lowers your risk, but doesn’t eliminate it. Auditing, testing, and compliance at the brand level are still required.
Q: What’s the goal of a “good” recall?
A: To be uneventful. Smooth execution, minimal headlines, and fast corrective action show regulators you’re competent and trustworthy.
How to prepare for a recall
Stay informed. Sign up for FDA recall alerts and monitor competitor recalls.
Build a recall SOP. Know the steps, timelines, and contacts before an emergency happens.
Audit your partners. Don’t assume testing or certifications tell the whole story.
Train your team. Make sure staff understand their role in a recall situation.
Stress test compliance. Run “mock recalls” the same way you’d run fire drills.
Preparation doesn’t prevent recalls entirely—but it does determine whether your brand survives one.
Scaling smart: final thoughts
Recalls aren’t just “worst-case scenarios.” They’re part of doing business in a regulated space. The brands that survive are the ones that plan ahead, train their teams, and treat compliance as a growth strategy, not a box to check.
If you’re growing—even just crossing into your first million in sales—it’s time to get serious about recall readiness.
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About Blue Ocean Regulatory
Blue Ocean Regulatory helps supplement and functional food brands launch and scale compliance. Core specialties include FDA/FTC label & claims review, substantiation dossiers, cGMP programs, manufacturer vetting, test & shelf-life strategies, and retailer/investor readiness. Our goal: build brands that last—and pass.