5 Significant Drug Recalls in US History & Why They Happened

Pharmaceutical commercials have earned a reputation for listing more hazards than benefits. While it may seem excessive, this is an important requirement from the FDA. The logic for this regulation is simple: drug companies who extol the benefits of a drug produces should also warn users of the hazardous—and sometimes deadly—side effects of their product. These warning requirements help ensure that drug companies do not make lofty promises without being honest about the risks of their products.

When a pharmaceutical company fails to advertise the risks of its drugs, the people who trusted it with their wellbeing pay the highest costs. Often, the drug companies which sell dangerous or defective products have some level of awareness of the danger of their products but fail to notify the public. When this happens, thousands of people suffer because of a pharmaceutical company’s prioritization of profits over responsibility. These are some of the most significant and impactful drug recalls in American history.


Thalidomide was a drug prescribed to help pregnant women suffering from morning sickness. Sold under the name Immunoprin, the drug caused the FDA to transform how it regulated drugs in the United States. Thalidomide was sold throughout the world an over-the-counter drug throughout the late 1950s. By 1961, the drug was found to be the cause of about 10,000 to 20,000 severe birth defects. According to the National Institutes of Health, this crisis was the “biggest man-made medical disaster ever.”

In the United States, the drug was never approved for sale. However, about 1,000 physicians prescribed the drug to approximately 20,000 women during a clinical testing program. After the crisis, Congress added the Kefauver-Harris Drug Amendments to the law, providing the FDA with the power to oversee drugs and required manufacturers to prove the safety of their products. Grünenthal, the manufacturer of the drug, later received criminal charges for negligent homicide and injury.

Diethylstilbestrol (DES)

Physicians prescribed diethylstilbestrol for over three decades to pregnant women to help prevent miscarriages and other complications during pregnancy. At the time, the medical community believed that some women did not produce enough estrogen for safe delivery, and DES would help compensate for this problem. Even though research revealed that DES was not effective in 1953, doctors continued to prescribe the drug. Then, in 1971 the FDA issued a Drug Bulletin warning physicians that DES caused a rare form of vaginal cancer to girls and women exposed to DES while in the womb.

Those suffering from complications caused by DES were able to secure a landmark product liability case in 1980. During this settlement, the Supreme Court of California ordered all DES manufacturers to pay a settlement proportionate to their share of the drug’s market while it was being sold.


Pfizer produced Bextra as an anti-inflammatory drug. Physicians prescribed the drug to treat inflammatory disorders and arthritis until the FDA blocked its sale in 2005. Researchers found that the drug was to blame for heart and stomach problems and could cause severe skin conditions. One of these skin conditions is Stevens-Johnson syndrome, a reaction that causes blistering on the skin and internal organs.


Also known as Rofecoxib, this drug was recalled in what many consider to be the largest in history. Like Bextra, Vioxx is an anti-inflammatory drug that was prescribed to treat pain caused by arthritis. More than 20 million people used the drug before researchers determined it increased the chance of heart attack and stroke. One report about Vioxx estimated that up to 140,000 people suffered from coronary heart disease because of the drug. Merck, the producer of Vioxx, settled for $4.8 billion.

The Vioxx recall caused the FDA and Merck to receive criticism for how they approached evidence of the drug’s dangers. Both bodies were accused of ignoring evidence of the drug’s dangers years before its eventual recall. In 2006, Merck sponsored a report on Vioxx and its recall which many criticized for being self-serving. The company spent $21 million for legal help to publish the report, which determined that Merck acted in good faith.


Fenfluramine/phentermine, stylized for sale as Fen-Phen, was one of the many “miracle” weight-loss pills of the 90s. Though it was sold modestly since the 1970s, an aggressive advertising campaign made the drug’s popularity soar in the 1990s. An estimated 6.5 million turned to this drug between 1970 and the late 1990s to help them lose weight before the FDA called for it to be taken off shelves. The FDA’s recall was in response to a slew of reports of pulmonary hypertension with those who took the drug. To date, over 50,000 victims have filed suit against Wyeth, Fen-Phen’s producer. Wyeth has lost an estimated $21 billion to legal defenses and damages for Fen-Phen.

What Should You Do After Suffering from a Drug’s Side Effects?

If you are suffering from the side effects of a drug that was supposed to help you, it’s time to contact a defective drug lawyer from Handler, Henning & Rosenberg LLC. Our attorneys have been fighting for clients since 1922, and we’ve won tens of millions of dollars for them over the last nine decades. We’ve helped clients recover damages from a variety of harmful drugs, so we have the experience and resources need to fight for your recovery.

Call our Pennsylvania defective drug attorneys today at (888) 498-3023 today for a free consultation of your case. You can be certain that our help is affordable because we only collect a fee if we win results!

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