United StatesErythromycin Tablets, USP 250 mg (30-count NDC 70710-1047-3 and 100-count NDC 70710-1047-1; lots M411146 exp. 08/2026, M502098 and M502097 exp. 01/2027, and M411145 exp. 08/2026) and Erythromycin Tablets, USP 500 mg (30-count NDC 70710-1048-3; lots M411147 exp. 08/2026 and M502100 and M502099 exp. 01/2027), manufactured by Zydus Lifesciences Ltd. and distributed by Zydus Pharmaceuticals (USA) Inc., sold nationwide in the U.S., are being recalled. The recall is due to CGMP deviations resulting in N‑Nitroso‑Desmethyl‑Erythromycin levels above the recommended acceptable intake limit.
What's being recalled
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).
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).
Recalling firm: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States.
How to identify it
Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026. Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027.
The hazard
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the U.S
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)