PhotoSandoz is recalling all quantities and lots within of Ranitidine Hydrochloride Capsules in the US.

The products are contaminated with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.

NDMA is classified as a probable substance that could cause cancer.

The firm says it has not received any reports of adverse events to date.

The following lots of the product, including 30-count, 60-count and 500-count bottles, are being recalled:

Product NameNDC NumberLot Nbr.Expiration DateDate of Manufacture
RANITIDINE 150mg Capsules 500 count0781-2855-05HD18624/30/20204/19/2017
RANITIDINE 150mg Capsules 500 count0781-2855-05HP94389/30/20209/5/2017
RANITIDINE 150mg Capsules 500 count0781-2855-05HP94399/30/20209/6/2017
RANITIDINE 150mg Capsules 500 count0781-2855-05HP94409/30/20209/5/2017
RANITIDINE 150mg Capsules 60 count0781-2855-60HC92664/30/20204/19/2017
RANITIDINE 150mg Capsules 60 count0781-2855-60HD18654/30/20204/19/2017
RANITIDINE 150mg Capsules 60 count0781-2855-60HP94419/30/20209/6/2017
RANITIDINE 150mg Capsules 60 count0781-2855-60JK79948/31/20218/7/2018
RANITIDINE 150mg Capsules 60 count0781-2855-60JK86598/31/20218/7/2018
RANITIDINE 300mg Capsules 30 count0781-2865-31HD86254/30/20204/27/2017
RANITIDINE 300mg Capsules 30 count0781-2865-31HD92754/30/20204/27/2017
RANITIDINE 300mg Capsules 30 count0781-2865-31HU22078/31/20208/24/2017
RANITIDINE 300mg Capsules 30 count0781-2865-31HX66763/31/20213/20/2018
RANITIDINE 300mg Capsules 30 count0781-2865-31HX66773/31/20213/20/2018

The recalled product can be identified by the NDC number and lot number provided above.

What to do

Customers who purchased the recalled product should continue taking their medication and speak to their physician or pharmacist on alternate healthcare treatment options.

Consumers with questions may contact Sandoz at (800) 525-8747 option # between 8:30am – 5:00pm Monday – Friday (EST) or online at www.us.sandoz.com for more information.

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