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Zydus Pharmaceuticals (USA) Inc: Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed b

DrugsSource: FDA (drug) · Date: 2026-05-27

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Zydus Pharmaceuticals (USA) Inc
Product
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).
Reason / hazard
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the U.S
Recall initiated
2026-04-29
Code info
Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.
Product quantity
23,880 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Pennington
State
NJ
Country
United States
Event id
98870
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