The U.S. Food and Drug Administration (FDA) assigned a risk level to 24,960 collagen dietary supplements sold nationwide on Amazon.
“The firm initiated a voluntary recall after [National Sanitation Foundation] NSF testing showed that labeled ingredient quantities did not align with analytical test results,” FDA officials said. “Manganese level was below label quantity.”
Under delivery is more frequent than most people realize, according to Ed McCormick, a food science consultant and founder of Cape Crystal Brands.
“Many consumers assume supplements are regulated like drugs or even packaged foods,” McCormick told NTD. “They’re not. Label accuracy relies heavily on manufacturer controls rather than pre-market verification. ‘Natural’ or ‘sold on Amazon’ does not guarantee consistency.”
The capsules are packaged in white bottles of 320 and have a black lid. Originally announced five months ago, the market withdrawal applies to seventy-eight 320-count units.
Since the Sept. 23, 2025, recall, the FDA assigned the neutraceuticals its third-highest risk label.
“For most consumers, the immediate risk is low,” McCormick said. “The larger issue is trust and effectiveness. Someone relying on the supplement to meet a nutritional need isn’t getting what they believe they’re taking, and that matters, particularly with long-term use.”
The FDA describes a Class 3 event on its website as products that violate regulations but are unlikely to cause health problems, such as minor labeling errors, while a Class 2 recall means the risk is temporary or has medically reversible adverse health consequences.
A Class 1 recall is defined as having a reasonable probability that the use of or exposure to will cause serious adverse health consequences or death.
"It reflects uneven quality control across the supplement space," McCormick said. "That doesn’t mean all supplements are unreliable, but it does mean consumers should exercise caution, and manufacturers should expect increased scrutiny when claims don’t align with reality.
Optiwize company leaders did not respond to requests for comment when asked how they became aware of the underdelivery.
“These discrepancies usually come to light when someone verifies whether the product actually matches its label claims,” McCormick added. "Minerals and vitamins can degrade, precipitate, or be dosed inconsistently, especially when formulation practices or quality testing are weak."