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Recall Observatory FDA recall evidence

Drug product

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).

D-0545-2026

April 29, 2026

Class II

Product summary

Firm
Zydus Pharmaceuticals (USA) Inc
Event
Event 98870
Status
Ongoing
Classification
Class II
Quantity
10,992 bottles
Official record key
drug-enforcement:D-0545-2026

Official wording

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

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

Distribution pattern: Nationwide within the U.S

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations