D-0545-2026Class II

Zydus Pharmaceuticals (USA) Inc

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2026-05-27

Distribution

Nationwide within the U.S

Firm state

Product quantity

10,992 bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

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).

Code / lot info

Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027.

Other recalls SPEQ maps to Risk Management & CAPA

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.