FDA Class II recall: antibiotic erythromycin tablets exceed the limit for a nitrosamine impurity — nationwide (Zydus)

The U.S. FDA classified Zydus Pharmaceuticals (USA) Inc.'s antibiotic recall as Class II (use may cause temporary or medically reversible adverse health consequences, with a low probability of serious harm) — recall number D-0545-2026, reported May 27, 2026, status ongoing (firm-initiated).

The affected product is erythromycin tablets (USP 500mg, 30 tablets per bottle, prescription-only; manufactured by Zydus Lifesciences Ltd., Ahmedabad, India). The reason is CGMP (current good manufacturing practice) deviations, with the nitrosamine impurity "N-Nitroso-Desmethyl-Erythromycin" present above the recommended acceptable intake limit. The recall was initiated April 29, 2026; distribution is nationwide; quantity 10,992 bottles.

Erythromycin is a macrolide antibiotic used to treat bacterial infections.

Why it matters: "nitrosamines" are a class of impurities that have become a significant issue across many medicines in recent years; some are of concern for cancer risk, and regulators worldwide set acceptable intake limits. Here, a deviation from manufacturing controls (CGMP) allowed the impurity to exceed the limit. The Class II rating reflects a "low probability of serious harm," but a drug with an impurity above the limit reaching nationwide distribution underscores the importance of pharmaceutical quality control. Patients taking it should not stop on their own; consult a doctor or pharmacist about whether their lot is affected and what to do (this article is general organization, not medical advice).