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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 23,880
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.
Part of a larger recall action
This product is one of 2 recalled by Zydus Pharmaceuticals (USA) Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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