Erythromycin Tablet, Film Coated
FDA Recall NDC 70710-1048
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Erythromycin (NDC 70710-1048). A significant event, classified as Class II, was initiated on Apr 29, 2026 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
April 2026 Class II Recall: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Recall Number
Class II Ongoing
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Apr 29, 2026
May 27, 2026
10,992 bottles
Recall Profile & Regulatory Data
Event ID
98870
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
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).
Batch or Lot Expiration Information
Lot# Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027.
Affected Packages Involved in this Recall
70710-1047-3Product
70710-1047-1Product
70710-1047-5Product
70710-1048-3Product
70710-1048-1Product
70710-1048-5Product
April 2026 Class II Recall: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Recall Number
Class II Ongoing
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Apr 29, 2026
May 27, 2026
23,880 bottles
Recall Profile & Regulatory Data
Event ID
98870
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).
Batch or Lot Expiration Information
Lot# Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.
Affected Packages Involved in this Recall
70710-1047-3Product
70710-1047-1Product
70710-1047-5Product
70710-1048-3Product
70710-1048-1Product
70710-1048-5Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
