FDA recall D-0408-2026 · initiated Mar 19, 2026
May cause temporary or medically reversible harm; low probability of serious harm.
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).