FDA Drug · D-0545-2026

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).

Class II · Ongoing

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

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Affected lots / codes — check yours against thisLots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027.
Recalling firm
Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Classification
Class II (temporary or reversible harm possible)
Status
Ongoing
Quantity
10,992 bottles
Distribution
Nationwide within the U.S
Recall initiated
April 29, 2026
Classified
May 20, 2026
Initiation
Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0545-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →