Ranitidine recall – Amneal Pharmaceuticals, LLC

November 13, 2019

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: March 13, 2020

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