Mylan Initiates Voluntary Nationwide Recall Nizatidine Capsules 150mg and 300mg



Description NDC Lot# Exp/Date
Nizatidine 150mg Cap 378515091 3086746 5/1/2020
Nizatidine 300mg Cap 378530093 3082876 1/1/2020
Nizatidine 300mg Cap 378530093 3082877 1/1/2020

Mylan Pharmaceuticals is conducting a voluntary nationwide recall to the consumer level of three (3) lots of Nizatidine 150mg and 300mg capsules due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA). A listing of the NDC and impacted lot numbers are identified. Affected product started shipping June 2017.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Mylan: Stericycle Mylan 888-628-0727