FDA Class II recall: antibiotic erythromycin tablets exceed the limit for a nitrosamine impurity — nationwide (Zydus)
Generics maker Zydus recalled erythromycin tablets (500mg) after a nitrosamine impurity (N-Nitroso-Desmethyl-Erythromycin) was found above the recommended acceptable intake limit. The FDA classified it Class II. Distributed nationwide.
Recall overview (primary data)
- ClassificationClass II
- Product typeDrug
- Recalling firmZydus Pharmaceuticals (USA) Inc
- ReasonCGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
- DistributionNationwide within the U.S
- Recall initiated2026-04-29
Key points
- Erythromycin tablets (500mg) had a nitrosamine impurity above the acceptable limit
- Impurity: N-Nitroso-Desmethyl-Erythromycin (caused by a CGMP deviation)
- FDA classified it Class II (D-0545-2026, reported May 27, 2026, ongoing)
- Distributed nationwide; 10,992 bottles (30 tablets each); made by Zydus (India)
- Nitrosamines have prompted many drug recalls — some of cancer-risk concern, with limits set
1A Class II antibiotic recall
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).
2The affected erythromycin tablets
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.
3What erythromycin is
Erythromycin is a macrolide antibiotic used to treat bacterial infections.
Why it matters
An example of nitrosamine impurity control — an increasingly important global quality issue. It underscores rigorous CGMP and helps patients and pharmacies identify affected lots.
FAQ
What are nitrosamines?
I am taking it — should I stop right away?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: D-0545-2026