Ranitidine

Ranitidine recalls: 5 FDA reports

Recalls involving Ranitidine. What was wrong with each batch, and how the FDA graded the risk.

5Reports
0Class I
3Ongoing
2020-01-08Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II5

By year reported

YearReports
20194
20201
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32

D-0632-2020  ·  Class II  ·  reported 2020-01-08  ·  Ongoing

Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Where it went
OR, NY, NJ
How much
23,090,000 tablets

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

D-0616-2020  ·  Class II  ·  reported 2019-12-18  ·  Ongoing

Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Where it went
Product was distributed throughout the United States.
How much
N/A

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

D-0615-2020  ·  Class II  ·  reported 2019-12-18  ·  Ongoing

Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product
Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
Where it went
Product was distributed throughout the United States.
How much
N/A

Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)

D-0182-2020  ·  Class II  ·  reported 2019-11-13  ·  Completed

Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Product
Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)
Where it went
Product was distributed to major distributors throughout the United States who may have further distributed the product.
How much
N/A

Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)

D-0181-2020  ·  Class II  ·  reported 2019-11-13  ·  Completed

Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Product
Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)
Where it went
Product was distributed to major distributors throughout the United States who may have further distributed the product.
How much
N/A
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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