Erythromycin 500 mg Tablets Recalled for Impurity Above Limits
Zydus Pharmaceuticals is recalling erythromycin 500 mg tablets nationwide due to the presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit, resulting from manufacturing deviations.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is FDA Class II with a chemical impurity (N-Nitroso-Desmethyl-Erythromycin) above acceptable limits, which carries potential for harm. Class II recalls meet the Severe threshold per the rubric.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling erythromycin tablets, USP, 500 mg, 30 tablets per bottle, distributed nationwide. The recall was initiated because the tablets contain N-Nitroso-Desmethyl-Erythromycin at levels above the recommended acceptable intake limit due to current good manufacturing practice (CGMP) deviations.
The affected product was manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals (USA) Inc. in Pennington, New Jersey. The recalled lot numbers are M411147 (expiring 08/2026), M502100 (expiring 01/2027), and M502099 (expiring 01/2027), affecting approximately 10,992 bottles.
Patients currently taking erythromycin from the recalled lots should contact their healthcare provider or pharmacist for guidance. Consumers should not discontinue use of erythromycin without consulting their healthcare provider, as abrupt discontinuation may result in treatment failure.
The recalled product
- Product
- ERYTHROMYCIN (ERYTHROMYCIN)
- Brand
- ERYTHROMYCIN
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Oral Tablet
- Hazard
- chemical-impurity
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lots: a) M411147
- Expires: 08/2026
- M502100
- M502099
- Expires: 01/2027.
Distribution
Distributed nationwide across the United States.