Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine


URGENT: VOLUNTARY DRUG RECALL 


Description NDC Lot# Exp/Date
Ranitidine Tablets, USP 150mg 53746025310 HD03119A 03/31/21
Ranitidine Tablets, USP 150mg 53746025310 HD03219A 03/31/21
Ranitidine Tablets, USP 150mg 53746025310 HE03119A 04/30/21
Ranitidine Tablets, USP 150mg 53746025310 HE03219A 04/30/21
Ranitidine Tablets, USP 150mg 65162025306 AR181690A 10/31/20
Ranitidine Tablets, USP 150mg 65162025306 AR181691A 10/31/20
Ranitidine Tablets, USP 150mg 65162025306 AR181806A 11/30/20
Ranitidine Tablets, USP 150mg 65162025306 AR190183A 01/31/21
Ranitidine Tablets, USP 150mg 65162025306 AR190184A 01/31/21
Ranitidine Tablets, USP 150mg 65162025310 AR180675A 04/30/20
Ranitidine Tablets, USP 150mg 65162025310 AR180868B 05/31/20
Ranitidine Tablets, USP 150mg 65162025310 AR190366B 02/28/21
Ranitidine Tablets, USP 150mg 65162025311 AR180559A 03/31/20
Ranitidine Tablets, USP 150mg 65162025311 AR180560A 03/31/20
Ranitidine Tablets, USP 150mg 65162025311 AR180594A 03/31/20
Ranitidine Tablets, USP 150mg 65162025311 AR180595A 03/31/20
Ranitidine Tablets, USP 150mg 65162025311 AR180829A 04/30/20
Ranitidine Tablets, USP 150mg 65162025311 AR180831A 05/31/20
Ranitidine Tablets, USP 150mg 65162025311 AR180832A 05/31/20
Ranitidine Tablets, USP 150mg 65162025311 AR180868A 05/31/20
Ranitidine Tablets, USP 150mg 65162025311 AR181807C 11/30/20
Ranitidine Tablets, USP 150mg 65162025311 AR190085A 12/31/20
Ranitidine Tablets, USP 150mg 65162025311 AR190086A 12/31/20
Ranitidine Tablets, USP 150mg 65162025311 AR190087A 12/31/20
Ranitidine Tablets, USP 150mg 65162025311 AR190124A 01/31/21
Ranitidine Tablets, USP 150mg 65162025311 AR190542B 03/31/21
Ranitidine Tablets, USP 150mg 65162025311 AR190609A 03/31/21
Ranitidine Tablets, USP 150mg 65162025311 AR190610A 03/31/21
Ranitidine Tablets, USP 150mg 65162025318 AR180483B 03/31/20
Ranitidine Tablets, USP 150mg 65162025318 AR181807B 11/30/20
Ranitidine Tablets, USP 150mg 65162025318 AR190008B 12/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR180869A 05/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR180870A 05/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR180871A 05/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR180872A 05/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR180995A 05/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR180996A 05/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR180997A 06/30/20
Ranitidine Tablets, USP 150mg 65162025350 AR180998A 06/30/20
Ranitidine Tablets, USP 150mg 65162025350 AR181158A 07/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR181159A 07/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR181160A 07/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR181161A 07/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR181692A 10/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR181693A 10/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR181694A 10/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR181709A 10/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR181710A 11/30/20
Ranitidine Tablets, USP 150mg 65162025350 AR181711A 11/30/20
Ranitidine Tablets, USP 150mg 65162025350 AR181808A 11/30/20
Ranitidine Tablets, USP 150mg 65162025350 AR190004A 12/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR190005A 12/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR190006A 12/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR190007A 12/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR190008A 12/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR190088A 12/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR190089A 12/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR190090A 12/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR190121A 12/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR190122A 12/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR190123A 12/31/20
Ranitidine Tablets, USP 150mg 65162025350 AR190125B 01/31/21
Ranitidine Tablets, USP 150mg 65162025350 AR190181A 01/31/21
Ranitidine Tablets, USP 150mg 65162025350 AR190182A 01/31/21
Ranitidine Tablets, USP 150mg 65162025350 AR190364A 02/28/21
Ranitidine Tablets, USP 150mg 65162025350 AR190365A 02/28/21
Ranitidine Tablets, USP 150mg 65162025350 AR190366A 02/28/21
Ranitidine Tablets, USP 150mg 65162025350 AR190509A 03/31/21
Ranitidine Tablets, USP 150mg 65162025350 AR190510A 03/31/21
Ranitidine Tablets, USP 300mg 65162025403 AR180519A 03/31/20
Ranitidine Tablets, USP 300mg 65162025403 AR180615A 03/31/20
Ranitidine Tablets, USP 300mg 65162025403 AR181795A 11/30/20
Ranitidine Tablets, USP 300mg 65162025403 AR181921B 12/31/20
Ranitidine Tablets, USP 300mg 65162025403 AR190705A 04/30/21
Ranitidine Tablets, USP 300mg 65162025410 AR180613A 03/31/20
Ranitidine Tablets, USP 300mg 65162025410 AR181156A 07/31/20
Ranitidine Tablets, USP 300mg 65162025410 AR181157A 07/31/20
Ranitidine Tablets, USP 300mg 65162025410 AR190418B 02/28/21
Ranitidine Tablets, USP 300mg 65162025425 AR180638A 03/31/20
Ranitidine Tablets, USP 300mg 65162025425 AR180640A 04/30/20
Ranitidine Tablets, USP 300mg 65162025425 AR180641A 04/30/20
Ranitidine Tablets, USP 300mg 65162025425 AR181920A 12/31/20
Ranitidine Tablets, USP 300mg 65162025425 AR181921A 12/31/20
Ranitidine Tablets, USP 300mg 65162025425 AR190414B 02/28/21
Ranitidine Tablets, USP 300mg 65162025425 AR190415A 02/28/21
Ranitidine Tablets, USP 300mg 65162025425 AR190416A 02/28/21
Ranitidine Tablets, USP 300mg 65162025425 AR190417A 02/28/21
Ranitidine Tablets, USP 300mg 65162025425 AR190418A 02/28/21
Ranitidine Tablets, USP 300mg 65162025425 AR190543A 03/31/21
Ranitidine Tablets, USP 300mg 65162025425 AR190544A 03/31/21
Ranitidine Tablets, USP 300mg 65162025425 AR190545A 03/31/21

  

Amneal Pharmaceuticals LLC is voluntarily, on a precautionary basis, recalling Ranitidine Tablets, USP, 150 mg and 300 mg to the consumer level. Ranitidine Tablets are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. A listing of the NDC numbers, and impacted lot numbers are identified. Affected product started shipping August 2018.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

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

Contact:

Amneal Pharmaceuticals: Amneal Stericycle 866-918-8768