The ranitidine withdrawal of 2020

On April 1, 2020, the Food and Drug Administration asked every manufacturer of ranitidine to pull its products from the US market immediately, prescription and over-the-counter alike. Ranitidine was a widely used heartburn and ulcer drug, sold under its brand name and as many generics. FDA's announcement¹ said the action meant ranitidine "will not be available for new or existing prescriptions or OTC use in the U.S."

The reason was a contaminant, N-nitrosodimethylamine (NDMA), and a finding about time. FDA had concluded that the amount of NDMA in some ranitidine products "increases over time and when stored at higher than room temperatures." A product that tested acceptably at the factory could, after months in a hot truck or a bathroom cabinet, exceed the limit.

FDA's own Q&A³ called it the first time the agency had requested withdrawal of all ranitidine products. This history follows the seven months between FDA's first public warning and the withdrawal, using the agency's own announcement log, its laboratory results and recall records in its enforcement database, and then looks at what later research found.

From a lab report to a market-wide warning

FDA said it "became aware of independent laboratory testing that found NDMA in ranitidine" in the summer of 2019, according to the April 2020 press release¹. On Sept. 13, 2019, the agency issued its first public statement on the finding, and recalls began within two weeks. FDA's running log of ranitidine announcements² records a recall of prescription capsules on Sept. 24 and of store-brand OTC tablets on Sept. 26.

At first, FDA did not tell people to stop. Its Sept. 26 notice said the agency was "not recommending individuals stop taking all ranitidine medicines at this time," while noting that other OTC products were approved for the same uses.

A measurement dispute ran alongside. On Oct. 2, 2019, FDA said the third-party laboratory's method heated samples, and that "the higher temperatures generated very high levels of NDMA from ranitidine products because of the test procedure," according to the log². The agency recommended an unheated method and said its own testing found "much lower levels of NDMA" than the outside lab had reported. Lower did not mean acceptable. FDA said its early, limited testing had still found unacceptable levels in some samples. The same pattern recurred months later with metformin, when a lab method again overstated NDMA (see our piece on nitrosamine impurities).

What FDA's laboratory found

On Nov. 1, 2019, FDA posted its test results⁴ for ranitidine and for nizatidine, a chemically similar acid reducer. "NDMA was present in all samples tested," the page says. The limit FDA applied was 0.096 micrograms (96 nanograms) a day, or 0.32 parts per million for ranitidine.

The table on that page covers 18 product listings, 14 of them ranitidine. Readings per tablet or dose ran from essentially zero to 0.86 micrograms in one prescription 300 mg product, about nine times the daily limit in a single dose. FDA also ran the drug through simulated stomach and intestinal fluid and reported "no additional NDMA generated in the stomach." Its summary at the time was that the levels found were "similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats."

On Dec. 4, 2019, FDA asked manufacturers of ranitidine and nizatidine to test every lot before release and to hold any lot over the limit, according to the log².

Timeline of the withdrawal

Why FDA moved from recalls to withdrawal

Lot-by-lot recalls work when the problem is fixed at the moment of manufacture. Ranitidine's problem was that the molecule itself appeared to degrade into NDMA after release. FDA said new testing, prompted by information from third-party laboratories, "confirmed that NDMA levels increase in ranitidine even under normal storage conditions," and that "the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA."

Janet Woodcock, then director of FDA's Center for Drug Evaluation and Research, explained the call in the press release¹: "We didn't observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don't know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured."

FDA's request covered every form, including injections and compounded products, according to FDA's question-and-answer page³. FDA told consumers at the time to stop using OTC ranitidine they had at home and dispose of it, and said patients on prescription ranitidine should talk with a health care professional about other options before stopping. The agency said its testing had not found NDMA in famotidine, cimetidine, esomeprazole, lansoprazole or omeprazole.

FDA stopped short of revoking the drug's legal status. "At this time, FDA is not withdrawing approvals" of ranitidine applications, the Q&A³ says, and the agency left a door open: if a company could show "through scientific data, that their ranitidine product is stable" and NDMA does not climb to unsafe levels, FDA "may consider allowing that ranitidine product back on the U.S. market." In FDA's Drugs@FDA database⁸, 77 of 84 ranitidine hydrochloride applications were listed as discontinued when GxRadar checked in November 2026.

What the recall records show

A market withdrawal request is not the same thing as a recall, and it shows up differently in the data. GxRadar searched FDA's openFDA enforcement database⁷ for ranitidine products with NDMA, abbreviated or spelled out, in the recall reason and found 102 records from 27 recall events by 24 firms, every one classed Class II. All were initiated between Sept. 23, 2019, and Jan. 15, 2020. None is dated after the April 2020 request.

Those records helped make 2019 the peak year for impurity recalls in GxRadar's recall data: 215 records in the impurities category that year, against 58 in 2017. Our explainer on how drug recalls work covers the difference between a firm-initiated recall and an FDA request.

Prices for one of the alternative acid reducers moved later, though the data cannot say why. GxRadar's analysis of CMS NADAC files⁹ shows pharmacies paid an average of 3.50 cents per famotidine 20 mg tablet in September 2019 and 3.44 cents in April 2020, the month of the withdrawal. The figure then rose to 5.79 cents in January 2021, the highest in our series, before falling back to 3.87 cents by December 2021 and 2.85 cents in October 2026, below where it stood before the withdrawal. Many factors move NADAC, and famotidine's 2020 rise came months after ranitidine left the market.

What later research found

One open question in 2019 was whether ranitidine turns into NDMA inside the body. FDA scientists tested that directly. In a randomized, placebo-controlled crossover trial of 18 healthy adults, published in JAMA in July 2021⁵, a 300 mg dose of ranitidine did not significantly increase 24-hour urinary excretion of NDMA compared with placebo, whether participants ate a diet with or without cured meats. The authors wrote that the findings "do not support that ranitidine is converted to NDMA in a general, healthy population."

That result addressed what happens in the body, and left the storage finding behind the withdrawal untouched. FDA continues to list ranitidine on its nitrosamine information page⁶ alongside ARBs, metformin and other drugs. GxRadar's guide to disposing of unused medicines covers what to do with old stock, and any question about a current acid-reducing prescription is one for a pharmacist or prescriber.