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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