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

Recall Summary Zydus Pharmaceuticals is recalling Erythromycin Tablets, USP, 250 mg in 30-count and 100-count bottles distributed nationwide because the medication contains higher-than-acceptable levels of N-Nitroso-Desmethyl-Erythromycin, a impurity formed during manufacturing. The affected product was manufactured by Zydus Lifesciences Ltd. in India and distributed throughout all 50 states. This is a Class II recall, meaning the product could cause adverse health effects.

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/c0afba4e-42ae-486b-821f-6896cabb8dcd