Drug recall D-0545-2026

Class II Ongoing reported May 27, 2026

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).

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Quantity
10,992 bottles
Distribution
Nationwide within the U.S
Type
Voluntary: Firm initiated
Recall initiated
April 29, 2026

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