Ranitidine capsule recall - Sandoz Inc.

September 24, 2019

On September 23, 2019, Sandoz, Inc. announced issued a voluntary recall of Ranitidine 150mg capsules, and 300mg capsules due to an elevated amount of an unexpected impurity (NDMA) found in the active pharmaceutical ingredient.

Product Name

NDC Number

Lot Nbr.

Expiration Date

Date of Manufacture

RANITIDINE 150mg Capsules 500 count 

0781-2855-05

HD1862

4/30/2020 

4/19/2017 

RANITIDINE 150mg Capsules 500 count 

0781-2855-05

HP9438

9/30/2020 

9/5/2017 

RANITIDINE 150mg Capsules 500 count 

0781-2855-05

HP9439

9/30/2020 

9/6/2017 

RANITIDINE 150mg Capsules 500 count 

0781-2855-05

HP9440

9/30/2020 

9/5/2017 

RANITIDINE 150mg Capsules 60 count

0781-2855-60

HC9266

4/30/2020 

4/19/2017 

RANITIDINE 150mg Capsules 60 count

0781-2855-60

HD1865

4/30/2020 

4/19/2017 

RANITIDINE 150mg Capsules 60 count

0781-2855-60

HP9441

9/30/2020 

9/6/2017 

RANITIDINE 150mg Capsules 60 count

0781-2855-60

JK7994

8/31/2021 

8/7/2018 

RANITIDINE 150mg Capsules 60 count

0781-2855-60

JK8659

8/31/2021 

8/7/2018 

RANITIDINE 300mg Capsules 30 count

0781-2865-31

HD8625

4/30/2020 

4/27/2017 

RANITIDINE 300mg Capsules 30 count

0781-2865-31

HD9275

4/30/2020 

4/27/2017 

RANITIDINE 300mg Capsules 30 count

0781-2865-31

HU2207

8/31/2020 

8/24/2017 

RANITIDINE 300mg Capsules 30 count

0781-2865-31

HX6676

3/31/2021 

3/20/2018 

RANITIDINE 300mg Capsules 30 count

0781-2865-31

HX6677

3/31/2021 

3/20/2018 

Additional information is available on the FDA's website:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated

Last updated: March 13, 2020

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