NOW recalls low-potency phosphatidylserine products

By Asia Sherman

- Last updated on GMT

© zorazhuang / Getty Images
© zorazhuang / Getty Images

Related tags NOW Health Group PhosphatidylSerine Product recall

NOW Health Group is voluntarily recalling several product lots containing phosphatidylserine supplements that failed to meet potency claimed on label.

The natural products manufacturer said that it was first alerted to the issue on Jan. 5 by a report​ and immediately launched an investigation that confirmed that some of the items in four lots indeed fell short of specification. 

“While there is no health risk in this situation, we take regulatory compliance and meeting label claims seriously, and giving consumers what they pay for even more seriously,” said Dan Richard, NOW Health Group VP of global sales and marketing. “We are issuing a voluntary recall and being transparent with the industry as a first step, to be followed by adding additional safeguards to our quality assurance protocols, especially for products we don’t make ourselves.” 

The recall covers lots #3316650 and #3309243 of NOW Phosphatidyl Serine Extra Strength 300 mg Softgels (50 count) and lots #3309194 and #3316624 of the Protocol for Life Balance practitioner brand, marketed to support cognitive health. NOW confirmed fewer than 10,000 units of the NOW brand and less than 3,000 units of the Protocol brand have been sold.

A blending issue

The investigation traced the inconsistencies to a contract manufacturer and attributed the source of the problem to “difficulty blending lecithin and achieving uniformity”.                                  

“Various product testing confirmed 30 mg and 55 mg per soft gel for some units and over 300 mg for others from the same lot,” Joshlyn Atoyebi, senior compliance manager at NOW, told NutraIngredients-USA. “[T]his is how we can tell that the problem is a blending issue with the contract manufacturer rather than a problem with the phosphatidylserine itself.”

NOW manufactures close to 80% of its dietary supplements at its in-house facilities across the U.S. and Canada and relies on 25 different contract manufacturers to supplement its internal capacities. It highlights its commitment to rigorous quality protocols, which include over 19,000 quality tests a month throughout the manufacturing process in its ISO-accredited labs. 

In the case of the phosphatidylserine lots, NOW said that products are formulated with a standard 324 mg, representing an 8% overage, and that pre-shipment samples tested in its third-party ISO-accredited analytical and microbiological lab passed at over 300 mg/softgels. 

“Obviously, in light of this situation, we will adjust our testing procedures and protocols with our contract manufacturers to ensure that this never happens again,” Atoyebi said. “NOW continues to focus on comprehensive testing and will only continue to get better.” 

Focus on quality assurance

This comprehensive testing extends to surveillance of other supplements on the market through a product policing program NOW launched in 2017 to check whether unfamiliar brands sold on Amazon meet label claims.

The 17 testing rounds to date have uncovered “subpar” to “baffling” to “abysmal” results tied to potency, labeling, contamination, adulteration and heavy metal level issues across over 150 tested products, including “serious failings” in the phosphatidylserine category​. 

NOW said that it is working with the U.S. Food and Drug Administration to execute its recall, which includes contacting all customers who ordered the affected products with detailed instructions on next steps. 

Related news

Related products

show more

Go Beyond the Ordinary: Cognitive Health-BacoMind

Go Beyond the Ordinary: Cognitive Health-BacoMind

Content provided by Natural Remedies Private Limited | 27-Feb-2024 | White Paper

Experience the potency of BacoMind®, the #1 branded bacopa with 9 key bioactives for unparalleled cognitive support.

Nootropics Report 2.0: Brain Health Insights

Nootropics Report 2.0: Brain Health Insights

Content provided by dsm-firmenich | 22-Feb-2024 | Insight Guide

The brain health market is constantly growing and evolving, with more consumers looking for innovative ways to support total mind and body wellness.

Krill oil supports six key areas of healthy aging

Krill oil supports six key areas of healthy aging

Content provided by Aker BioMarine | 14-Feb-2024 | White Paper

The global population is getting older—according to WHO by 2050 the world’s population over 60 years will double and the population above 80 years will...

Consumers' growing demand for Omegas

Consumers' growing demand for Omegas

Content provided by Fruit d'Or | 13-Feb-2024 | White Paper

Consumers are increasingly interested in the benefits of omegas supplements. According to forecasts for 2023–2030, the global omega-3 market is expected...

Related suppliers

Follow us


View more