NOW Health Group (Bloomingdale, IL) 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.Testing has shown that some units of these lot numbers do not meet label claim. There was an issue with the homogeneity of the material throughout the lots causing some units to test below the stated label claim while others tested to specification.
NOW was first alerted to the low potency issue by a ConsumerLabs.com report on Jan. 5, 2024 and, surprised at the results given NOW’s industry-leading quality protocols, immediately began an investigation. NOW’s specification is to add 8 percent overage for this product, meaning 324 mg Phosphatidyl Serine is input into this product normally, using a trademarked ingredient. Because NOW’s in-house soft gels manufacturing capacity at the Sparks, NV facility doesn’t fill all the demand, the company uses contract manufacturers for some soft gel 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/soft gels. However, the investigation this week determined that the lot is inconsistent, indicating that the contract manufacturer is 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. “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.”
NOW is working with the U.S. Food and Drug Administration (FDA) to execute the voluntary recall, which includes contacting all customers that ordered the affected products with detailed instructions on next steps.