Erythromycin Tablets Recalled for Impurity Above Acceptable Limits
Zydus Pharmaceuticals is recalling Erythromycin Tablets, 250 mg, nationwide because certain lots contain N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit due to CGMP 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 an FDA Class II recall involving a contaminant (N-Nitroso-Desmethyl-Erythromycin) above acceptable limits in a prescription drug due to CGMP deviations. Although no illnesses are reported in the source, the presence of a potentially harmful impurity in a widely distributed pharmaceutical product meeting the Class II threshold meets the Severe criterion.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Erythromycin Tablets, USP, 250 mg (30-count and 100-count bottles) distributed nationwide. The recall affects specific lots: M411146 (expires 08/2026), M502098 and M502097 (expire 01/2027), and M411145 (expires 08/2026). A total of 23,880 bottles are affected.
The recall was initiated because the recalled lots contain N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit. This issue resulted from Current Good Manufacturing Practice (CGMP) deviations.
Patients taking the affected medication should contact their healthcare provider or pharmacist for guidance. Do not stop taking the medication without consulting a healthcare professional. The tablets were manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals (USA) Inc. in Pennington, NJ.
The recalled product
- Product
- ERYTHROMYCIN (ERYTHROMYCIN)
- Brand
- ERYTHROMYCIN
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Prescription Antibiotic
- Hazard
- impurity-nitroso-compound
- 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 (7)
- Lots: a) M411146
- Expires: 08/2026
- M502098
- M502097
- Expires: 01/2027
- b) M411145
- Expires: 08/2026.
Distribution
Distributed nationwide across the United States.