According to the company’s announcement, testing determined that some units did not meet label claims due to there being an issue with homogeneity of the material. There is no danger to consumers.
NOW Health Group (Bloomingdale, IL) has announced the that it is conducting a voluntary recall of NOW Phosphatidyl Serine Extra Strength 300 mg Softgels, 50 count, Product Code 2392, Lots #3316650 and #3309243 and Protocol For Life Balance® Product Code P2392, Lots #3309194 and #3316624. According to the company’s announcement, testing determined that some units in those lot numbers did not meet label claims due to there being an issue with homogeneity of the material. This caused some of the units to test below stated label claims, through others tested to the right specifications.
The company explained that it was first alerted to the low potency issue by a ConsumerLabs.com report published in January 5, 2024. NOW’s specifications demand that 8% of overage is added for this product to ensure all products meet label claims over shelf life. The company states that because its Sparks, Nevada facility cannot fill all the demand for softgel manufacturing, contract manufacturers are used for some softgel products, including the products in question. According to the company, pre-shipment samples of phosphatidyl serine passed over 300 mg in its third-party ISO- accredited analytical and micro lab, but investigation this week found a great deal of inconsistency. This indicates that the contract manufacturer has been having difficulty blending lecithin and achieving uniformity.
“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, vice president of Global Sales and Marketing, in a press release. “We appreciate being alerted to this issue by ConsumerLab.com, which is a catalyst to reexamine our already robust quality assurance oversight. 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 QA protocols, especially for products we don’t make ourselves.”
The company is working with FDA to execute the voluntary recall and contact all effected consumers to provide them detailed instructions on next steps.