Who Helps With Recall Plans and Simulations For Supplement Brands?

A recall is one of the most damaging events a supplement brand can face. Whether triggered by an FDA finding, a retailer, or a consumer complaint, recalls destroy trust and create costly fallout. Yet many supplement brands lack a written recall plan, a violation in itself under FDA’s requirements.

FDA expects every supplement company to maintain a recall procedure that includes roles, communication steps, and lot tracing. Without it, a recall becomes chaotic and far more damaging than necessary.

A common misconception is that supplement manufacturers would be the ones that execute the recall when in fact, that is not the case. The brand is responsible for executing the recalls and the manufacturer only plays a behind-the-scene supportive role.

At Blue Ocean Regulatory, we design recall plans tailored to supplement brands, that are aligned with FDA requirements and in line with best practices given that Blue Ocean Regulatory has been involved in brand recalls. We also conduct mock recalls, testing your team’s ability to execute under pressure. These simulations identify weaknesses in your process before they matter.

One functional powder brand used us for their recall needs – they called us on a Thursday and by Saturday, the recall was executed in full confidence by the FDA. Monthly reports were provided to the FDA and smoothly closed out in 3 months and with little reputation damage along the way.

Preparedness is what separates brands that survive recalls from those that collapse under the pressure. With the right plan and practice, your business can protect consumers and preserve its reputation even in the toughest situations.