Zydus Pharmaceuticals (usa) Inc: Erythromycin Tablets, Usp, 250 Mg, 30 Tablets Per Bottle

Zydus Pharmaceuticals is recalling Erythromycin Tablets, USP, 250 mg in both 30-count and 100-count bottles distributed nationwide because the medication contains higher-than-acceptable levels of a chemical impurity called N-Nitroso-Desmethyl-Erythromycin. The recall affects all U.S. states and was initiated due to manufacturing process deviations. This is a prescription medication, so the recall applies to patients who have this specific antibiotic product.

Recalling firm

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

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

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-04-29

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide within the U.S

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/3793c4ec-4991-443e-a04b-b5cb255671e9