Bloomingdale, IL—NOW Health Group has issued 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. NOW is working with FDA to execute the voluntary recall, which includes contacting all customers that ordered the affected products with detailed instructions on next steps.
The reason for the recall
Testing revealed that some units of these lot numbers do not meet label claim, NOW reported, explaining that there was an issue with the homogeneity of the material throughout the lots. This caused some units to test below the stated label claim, while other units tested to specification.
A ConsumerLabs.com report on January 5, 2024 first alerted NOW to the low potency issue, and NOW immediately began its own investigation. The company explained: "NOW’s specification is to add 8% overage for this product, meaning 324 mg Phosphatidyl Serine is input into this product normally, using a trademarked ingredient. Because NOW’s in-house softgels manufacturing capacity at the Sparks, Nevada facility doesn’t fill all the demand, the company uses contract manufacturers for some softgel products, including this one. The pre-shipment samples of this lot NOW tested in its third-party ISO-accredited analytical and micro lab passed at over 300 mg/softgels. However, the investigation this week determined that the lot is inconsistent, indicating that the contract manufacturer is having difficulty blending lecithin and achieving uniformity."
No health risk
Dan Richard, NOW Health Group VP of Global Sales and Marketing, added in the press release: “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. 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.”
