Ranitidine recalls

The FDA has published 55 recalls involving Ranitidine since 2012. The latest was reported on 14 Oct 2020. Most were for nitrosamine impurity. Dr. Reddy's Laboratories has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls55since 2012

Last 12 months0reported

Class I00% of total

Ongoing7latest 14 Oct 2020

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 54 98%Class III 1 2%

Why ranitidine is recalled

Companies

Brands

Ranitidine59%
Ranitidine Hydrochloride24%

By year

20201527%
20193665%
201812%
201412%
201312%
201212%

Ongoing ranitidine recalls

7 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 Syrup Oral Solution 15 mg/mL fl. oz recalled	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
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 150 mg a) recalled by Amneal Pharmaceuticals	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 300 mg recalled by Amneal PharmaceuticalsRanitidine	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 300 mg - a) recalled by Amneal Pharmaceuticals	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide

All ranitidine recalls, newest first

55 total

Reported	Class	Recall	Company	Reason	Where
14 Oct 2020Drug	CLASS II	Ranitidine 150 mg, a) 60 Tabs recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	FL, GA
14 Oct 2020Drug	CLASS II	Ranitidine 300 mg, 30 Tabs recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	FL, GA
18 Mar 2020Drug	CLASS II	Ranitidine Tablets, USP, 150 mg x 10 blister card) recalled	American Health Packaging	Nitrosamine Impurity	Nationwide
18 Mar 2020Drug	CLASS II	Ranitidine Oral Solution, USP, 150 mg/, [ x Dose Cups recalled	Precision Dose	Nitrosamine Impurity	Nationwide
12 Feb 2020Drug	CLASS II	ranitidine hydrochloride, USP a) bottles recalled	PD-Rx Pharmaceuticals	Nitrosamine Impurity	12 states
12 Feb 2020Drug	CLASS II	Ranitidine Hydrochloride (powder) recalled	Spectrum Laboratory Products	Nitrosamine Impurity	11 states
29 Jan 2020Drug	CLASS II	Ranitidine Tablets, 150 mg, a) bottles recalled	Preferred Pharmaceuticals	Nitrosamine Impurity	7 states
29 Jan 2020Drug	CLASS II	Ranitidine Tablets, 300 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Nitrosamine Impurity	7 states
29 Jan 2020Drug	CLASS II	Ranitidine Tablets, USP 300 mg a) recalled by Denton Pharma	Denton Pharma	Nitrosamine Impurity	Nationwide
29 Jan 2020Drug	CLASS II	Ranitidine Tablets, USP 150 mg , a) recalled by Denton Pharma	Denton Pharma	Nitrosamine Impurity	Nationwide
15 Jan 2020Drug	CLASS II	Ranitidine Capsules 150 mg, (a) bottles recalled by Appco Pharma	Appco Pharma	Nitrosamine Impurity	NJ
15 Jan 2020Drug	CLASS II	Ranitidine 150 mg tablets, 130 count bottles recalled	AAA Pharmaceutical	Nitrosamine Impurity	NJ
15 Jan 2020Drug	CLASS II	Ranitidine 150 mg tablets, 24 count bottles recalled	AAA Pharmaceutical	Nitrosamine Impurity	NJ
15 Jan 2020Drug	CLASS II	Ranitidine Capsules 300 mg recalled by Appco Pharma	Appco Pharma	Nitrosamine Impurity	NJ
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 Syrup Oral Solution 15 mg/mL fl. oz recalled	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
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 150 mg a) recalled by Amneal Pharmaceuticals	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 300 mg recalled by Amneal PharmaceuticalsRanitidine	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 300 mg - a) recalled by Amneal Pharmaceuticals	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 150 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Nitrosamine Impurity	CA, FL
4 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 300 mg recalled by AVKARE	Avkare	Nitrosamine Impurity	Nationwide
4 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 150 mg recalled by AVKARE	Avkare	Nitrosamine Impurity	Nationwide
20 Nov 2019Drug	CLASS II	Ranitidine Capsules 300 mg recalled by Novitium Pharma	Novitium Pharma	Nitrosamine Impurity	Nationwide
20 Nov 2019Drug	CLASS II	Ranitidine Capsules 300 mg recalled by Novitium Pharma	Novitium Pharma	Nitrosamine Impurity	Nationwide
20 Nov 2019Drug	CLASS II	Ranitidine Capsules 150 mg recalled by Novitium Pharma	Novitium Pharma	Nitrosamine Impurity	Nationwide
20 Nov 2019Drug	CLASS II	Ranitidine Capsules 150 mg recalled by Novitium Pharma	Novitium Pharma	Nitrosamine Impurity	Nationwide
13 Nov 2019Drug	CLASS II	Ranitidine Tablets, USP 75 mg, a.) bottles recalled	Dr. Reddy's Laboratories	Nitrosamine Impurity	Nationwide
13 Nov 2019Drug	CLASS II	Ranitidine Tablets, USP 150 mg, a.) bottles recalled	Dr. Reddy's Laboratories	Nitrosamine Impurity	Nationwide
13 Nov 2019Drug	CLASS II	Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) bottles recalledRanitidine Hydrochloride	Dr. Reddy's Laboratories	Nitrosamine Impurity	Nationwide

Should you stop taking Ranitidine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.