FDA recall D-0598-2025 · initiated Jul 29, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.