Ranitidine recall – Amneal Pharmaceuticals, LLC

November 15, 2019

Updated: 11/13/19

On November 8, 2019, Amneal Pharmaceuticals, LLC issued a voluntary recall of all of its ranitidine medications due to an elevated amount of an unexpected impurity (NDMA) found in the active pharmaceutical ingredient.

Express Scripts will mail letters to patients who have received medication impacted by the recall.

The manufacturer recommends that consumers who have recalled Ranitidine tablets and Ranitidine Syrup (Ranitidine Oral Solution) from Amneal Pharmaceuticals should stop using the product and call Stericycle at 866-918-8768, Monday – Friday, 8:00 am – 5:00 pm, EST for further information. Patients taking prescription ranitidine who wish to discontinue use should talk to their prescriber about other treatment options. People taking OTC ranitidine may consider using other OTC products approved for their condition.

Product	Strength	Pack Size	NDC Number
Ranitidine Tablets, USP	150 mg	60 count	65162-253-06
Ranitidine Tablets, USP	150 mg	100 count	65162-253-10
Ranitidine Tablets, USP	150 mg	180 count	65162-253-18
Ranitidine Tablets, USP	150 mg	500 count	65162-253-50
Ranitidine Tablets, USP	150 mg	1000 count	65162-253-11
Ranitidine Tablets, USP	300 mg	30 count	65162-254-03
Ranitidine Tablets, USP	300 mg	100 count	65162-254-10
Ranitidine Tablets, USP	300 mg	250 count	65162-254-25
Ranitidine Tablets, USP	300 mg	1000 count	65162-254-11
Ranitidine Tablets, USP	150 mg	500 count	53746-253-05
Ranitidine Tablets, USP	150 mg	1000 count	53746-253-10
Ranitidine Syrup (Ranitidine Oral Solution, USP)	15 mg/mL; 16 fl. oz.	473 mL	65162-664-90

Ranitidine Tablets, USP, 150 mg
Description	Lot#	Expiration Date
Ranitidine Tablets, USP 150mg	AR180483B	03/31/2020
Ranitidine Tablets, USP 150mg	AR180559A	03/31/2020
Ranitidine Tablets, USP 150mg	AR180560A	03/31/2020
Ranitidine Tablets, USP 150mg	AR180594A	03/31/2020
Ranitidine Tablets, USP 150mg	AR180595A	03/31/2020
Ranitidine Tablets, USP 150mg	AR180675A	04/30/2020
Ranitidine Tablets, USP 150mg	AR180829A	04/30/2020
Ranitidine Tablets, USP 150mg	AR180831A	05/31/2020
Ranitidine Tablets, USP 150mg	AR180832A	05/31/2020
Ranitidine Tablets, USP 150mg	AR180868A	05/31/2020
Ranitidine Tablets, USP 150mg	AR180868B	05/31/2020
Ranitidine Tablets, USP 150mg	AR180869A	05/31/2020
Ranitidine Tablets, USP 150mg	AR180870A	05/31/2020
Ranitidine Tablets, USP 150mg	AR180871A	05/31/2020
Ranitidine Tablets, USP 150mg	AR180872A	05/31/2020
Ranitidine Tablets, USP 150mg	AR180995A	05/31/2020
Ranitidine Tablets, USP 150mg	AR180996A	05/31/2020
Ranitidine Tablets, USP 150mg	AR180997A	06/30/2020
Ranitidine Tablets, USP 150mg	AR180998A	06/30/2020
Ranitidine Tablets, USP 150mg	AR181158A	07/31/2020
Ranitidine Tablets, USP 150mg	AR181159A	07/31/2020
Ranitidine Tablets, USP 150mg	AR181160A	07/31/2020
Ranitidine Tablets, USP 150mg	AR181161A	07/31/2020
Ranitidine Tablets, USP 150mg	AR181690A	10/31/2020
Ranitidine Tablets, USP 150mg	AR181691A	10/31/2020
Ranitidine Tablets, USP 150mg	AR181692A	10/31/2020
Ranitidine Tablets, USP 150mg	AR181693A	10/31/2020
Ranitidine Tablets, USP 150mg	AR181694A	10/31/2020
Ranitidine Tablets, USP 150mg	AR181709A	10/31/2020
Ranitidine Tablets, USP 150mg	AR181710A	11/30/2020
Ranitidine Tablets, USP 150mg	AR181711A	11/30/2020
Ranitidine Tablets, USP 150mg	AR181806A	11/30/2020
Ranitidine Tablets, USP 150mg	AR181807B	11/30/2020
Ranitidine Tablets, USP 150mg	AR181807C	11/30/2020
Ranitidine Tablets, USP 150mg	AR181808A	11/30/2020
Ranitidine Tablets, USP 150mg	AR190004A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190005A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190006A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190007A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190008A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190008B	12/31/2020
Ranitidine Tablets, USP 150mg	AR190085A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190086A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190087A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190088A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190089A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190090A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190121A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190122A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190123A	12/31/2020
Ranitidine Tablets, USP 150mg	AR190124A	01/31/2021
Ranitidine Tablets, USP 150mg	AR190125B	01/31/2021
Ranitidine Tablets, USP 150mg	AR190181A	01/31/2021
Ranitidine Tablets, USP 150mg	AR190182A	01/31/2021
Ranitidine Tablets, USP 150mg	AR190183A	01/31/2021
Ranitidine Tablets, USP 150mg	AR190184A	01/31/2021
Ranitidine Tablets, USP 150mg	AR190364A	02/28/2021
Ranitidine Tablets, USP 150mg	AR190365A	02/28/2021
Ranitidine Tablets, USP 150mg	AR190366A	02/28/2021
Ranitidine Tablets, USP 150mg	AR190366B	02/28/2021
Ranitidine Tablets, USP 150mg	AR190509A	03/31/2021
Ranitidine Tablets, USP 150mg	AR190510A	03/31/2021
Ranitidine Tablets, USP 150mg	AR190542B	03/31/2021
Ranitidine Tablets, USP 150mg	AR190609A	03/31/2021
Ranitidine Tablets, USP 150mg	AR190610A	03/31/2021
Ranitidine Tablets, USP 150mg	HD03119A	03/31/2021
Ranitidine Tablets, USP 150mg	HD03219A	03/31/2021
Ranitidine Tablets, USP 150mg	HE03119A	04/30/2021
Ranitidine Tablets, USP 150mg	HE03219A	04/30/2021

Ranitidine Tablets , USP, 300 mg
Description	Lot#	Expiration Date
Ranitidine Tablets, USP 300mg	AR180519A	03/31/2020
Ranitidine Tablets, USP 300mg	AR180613A	03/31/2020
Ranitidine Tablets, USP 300mg	AR180615A	03/31/2020
Ranitidine Tablets, USP 300mg	AR180638A	03/31/2020
Ranitidine Tablets, USP 300mg	AR180640A	04/30/2020
Ranitidine Tablets, USP 300mg	AR180641A	04/30/2020
Ranitidine Tablets, USP 300mg	AR181156A	07/31/2020
Ranitidine Tablets, USP 300mg	AR181157A	07/31/2020
Ranitidine Tablets, USP 300mg	AR181795A	11/30/2020
Ranitidine Tablets, USP 300mg	AR181920A	12/31/2020
Ranitidine Tablets, USP 300mg	AR181921A	12/31/2020
Ranitidine Tablets, USP 300mg	AR181921B	12/31/2020
Ranitidine Tablets, USP 300mg	AR190414B	02/28/2021
Ranitidine Tablets, USP 300mg	AR190415A	02/28/2021
Ranitidine Tablets, USP 300mg	AR190416A	02/28/2021
Ranitidine Tablets, USP 300mg	AR190417A	02/28/2021
Ranitidine Tablets, USP 300mg	AR190418A	02/28/2021
Ranitidine Tablets, USP 300mg	AR190418B	02/28/2021
Ranitidine Tablets, USP 300mg	AR190543A	03/31/2021
Ranitidine Tablets, USP 300mg	AR190544A	03/31/2021
Ranitidine Tablets, USP 300mg	AR190545A	03/31/2021
Ranitidine Tablets, USP 300mg	AR190705A	04/30/2021

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL
Description	Lot#	Expiration Date
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL	06648001A	11/01/2019
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL	06648003A	04/01/2020
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL	06649001A	01/01/2021

Additional information is available on the FDA’s website:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-ranitidine-tablets-usp-150mg-and-300mg

Last updated: December 08, 2023

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