Ranitidine recalls

The FDA has published 34 recalls involving Ranitidine since 2013. The latest was reported on 18 Mar 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 recalls34since 2013

Last 12 months0reported

Class I00% of total

Ongoing6latest 18 Mar 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 33 97%Class III 1 3%

Why ranitidine is recalled

Companies

Brands

Ranitidine515%
Ranitidine Hydrochloride26%

By year

2020721%
20192471%
201813%
201413%
201313%

Ongoing ranitidine recalls

6 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 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
6 Nov 2019Drug	CLASS III	Ranitidine Tablets USP,150 mg recalled by AuroMedics Pharma	AuroMedics Pharma	Manufacturing (CGMP) Deviations	Nationwide

All ranitidine recalls, newest first

34 total

Reported	Class	Recall	Company	Reason	Where
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
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 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 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

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.