Ranitidine recalls

Ranitidine products have been recalled 5 times, most recently on 8 Jan 2020. The recalling company is usually Dr. Reddy's Laboratories. The most common reason is nitrosamine impurity.

Total recalls5since 2019

Last 12 months0reported

Class I00% of total

Ongoing3latest 8 Jan 2020

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 5 100%Class III 0 0%

Why ranitidine is recalled

Nitrosamine Impurity5100%

Companies

Product types

Stomach & Acid Reflux Medication5100%

By year

2020120%
2019480%

Ongoing ranitidine recalls

3 active

Reported	Class	Recall	Company	Reason	Where
8 Jan 2020Drug	CLASS II	Ranitidine Tablets, USP 150mg, Country of Origin: India recalledRanitidine	Granules India	Nitrosamine Impurity	NJ, NY, OR
18 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 150 mg recalled by Amneal PharmaceuticalsRanitidine	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 300 mg recalled by Amneal PharmaceuticalsRanitidine	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide

All ranitidine recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
8 Jan 2020Drug	CLASS II	Ranitidine Tablets, USP 150mg, Country of Origin: India recalledRanitidine	Granules India	Nitrosamine Impurity	NJ, NY, OR
18 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 150 mg recalled by Amneal PharmaceuticalsRanitidine	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 300 mg recalled by Amneal PharmaceuticalsRanitidine	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
13 Nov 2019Drug	CLASS II	Dr. Reddy's Ranitidine Tablets, USP 75 mg recalledRanitidine	Dr. Reddy's Laboratories	Nitrosamine Impurity	Nationwide
13 Nov 2019Drug	CLASS II	Dr. Reddy's Ranitidine Tablets, USP 150 mg recalledRanitidine	Dr. Reddy's Laboratories	Nitrosamine Impurity	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.