FDA-Drug2026-05-27Class IICHEMICAL
Zydus Pharmaceuticals erythromycin tablets recalled for nitrosamine impurity above safe limits
OTHERNationwide distribution
Zydus erythromycin tablets recalled for nitrosamine impurity
Zydus Pharmaceuticals is recalling erythromycin 500 mg tablets because testing found a chemical impurity (N-Nitroso-Desmethyl-Erythromycin) at levels higher than FDA's recommended safe intake limit. The impurity resulted from manufacturing process deviations at the maker in India. No injuries have been reported.
- Check if you have erythromycin from Zydus with lot numbers M411147, M502100, or M502099 (expiration dates 08/2026 or 01/2027).
- Contact your pharmacy or doctor if you have affected tablets.
- Do not stop taking your antibiotic abruptly; your doctor can provide a replacement or alternative medication.
Hazard
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Sold states
Nationwide within the U.S
Affected count
10,992 bottles
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0545-2026More Zydus Pharmaceuticals (USA) Inc recalls
- FDA-Drug2026-05-27Zydus Pharmaceuticals erythromycin tablets recalled for elevated nitrosamine impurity
- FDA-Drug2026-03-18Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
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