HOW DO YOU

Stop Taking

IF YOU

DON’T KNOW

IT’S BEEN

RECALLED?

RECALLED

MEDICATION

HOW DO YOU

Stop Taking

IF YOU

DON’T KNOW

IT’S BEEN

RECALLED?

RECALLED

MEDICATION

HOW DO YOU

Stop Taking

RECALLED

MEDICATION

IF YOU

DON’T KNOW

IT’S BEEN

RECALLED?

HOW DO YOU

Stop Taking

RECALLED

MEDICATION

IF YOU

DON’T KNOW

IT’S BEEN

RECALLED?

HOW DO YOU

Stop Taking

IF YOU

DON’T KNOW

IT’S BEEN

RECALLED?

RECALLED

MEDICATION

HOW DO YOU

Stop Taking

IF YOU

DON’T KNOW

IT’S BEEN

RECALLED?

RECALLED

MEDICATION

HOW DO YOU

Stop Taking

IF YOU

DON’T KNOW

IT’S BEEN

RECALLED?

RECALLED

MEDICATION

HOW DO YOU

Stop Taking

RECALLED

MEDICATION

IF YOU DON’T KNOW

IT’S BEEN RECALLED?

HOW DO YOU

Stop Taking

RECALLED

MEDICATION

IF YOU

DON’T KNOW

IT’S BEEN

RECALLED?

HOW DO YOU

Stop Taking

IF YOU

DON’T KNOW

IT’S BEEN

RECALLED?

RECALLED

MEDICATION

How Do You Stop Taking Recalled Medication If You Don’t Know It’s Been Recalled?

FDA recalls are always voluntary and sometimes haphazard—and the agency doesn’t want more authority to protect consumers.

In mid-September the U.S. Food and Drug Administration received a 19-page document with some startling claims about a popular medicine. The online pharmacy Valisure, which tests prescription drugs before dispensing them, said it had found extremely high levels of a probable human carcinogen in the antacid ranitidine, best known under the brand name Zantac. Millions of people around the world use ranitidine; it’s available both with a prescription and over the counter. As for the carcinogen, NDMA, the FDA knew it well: For more than a year the agency had been recalling batches of the blood pressure medication valsartan because they were contaminated with it.

The FDA issued an alert, one that seemed to downplay Valisure’s findings. The agency said it had learned that some ranitidine medicines contained low levels of NDMA, but it wasn’t advising people to stop taking the drug. Those with prescriptions could contact their doctors—if they were worried—and everyone else could consider alternatives on drugstore shelves. In fact, Valisure had found high levels of NDMA in every version of ranitidine it tested and concluded the problem was inherent to the molecule itself. In other words, if Valisure is correct, there is no safe version of ranitidine.

Company Actions to Pull Zantac in the U.S.

Date Company
Sept. 23
Sandoz
Sept. 28
CVS
Sept. 30
Walgreen
Sept. 30
Rite Aid
Oct. 1
Dr. Reddy’s
Oct. 2
Walmart
Oct. 8
GlaxoSmithKline
Oct. 18
Sanofi
Source: Valisure

The muted quality of the FDA’s statement didn’t stop concern from going global. The European Medicines Agency had issued its own warning that same day. Singapore health officials pulled eight brands of ranitidine off shelves. South Korean authorities conducted their own tests and banned sales. Canada’s regulators asked companies to stop distributing ranitidine, and some of the country’s manufacturers recalled their drugs. One of India’s biggest generics manufacturers suspended ranitidine supplies. GlaxoSmithKline Plc, the company that originally developed Zantac, halted global distribution. Sandoz Inc. announced it was recalling some of its ranitidine. Several U.S. companies, including CVS, Rite Aid, Walgreen, and Walmart, halted distribution. Memorial Sloan Kettering Cancer Center said it would no longer offer ranitidine to its patients.

By mid-October, a month after the FDA’s alert, at least two dozen countries had pulled ranitidine from stores or halted its distribution. Numerous companies had acted on their own to slow or stop the supply of the drug. The FDA continued to conduct tests.

Finally, on Nov. 1, the agency announced that it had found higher-than-acceptable levels of NDMA in some ranitidine—though not nearly as high as Valisure detected. The FDA then deployed the strongest weapon available to it: The agency asked manufacturers to voluntarily recall some of the Zantac on the market.

How Other Governments Reacted to the Zantac Finding Before the FDA Issued Its Voluntary Recall on Nov. 1

  • Sales or distribution ban
  • Recall
  • Both sales or distribution ban and recall
  • Other action, such as warning or import ban