Injury Lawyers Who Truly Care

Understanding the pharmaceutical drug recall process

On Behalf of | Jun 29, 2017 | Products Liability

It is important that pharmaceutical drugs are safe for patients, and in the United States, they are required to be safe for patients. If it is determined that a drug poses a health threat to patients, it may be recalled. It is important for patients and consumers to understand why and how drugs can be pulled from the market and the legal protections they have if they have been harmed by a defective or dangerous drug.

Pharmaceutical drugs are regulated by the Food and Drug Administration or FDA. Once a drug has been approved by the FDA, the FDA continues to monitor the drug while it is on the market and available for patients and consumers. Potential problems with drugs can be reported to the Food and Drug Administration online or otherwise. Doctors make determinations concerning drugs to recommend to patients and researchers study and evaluate the effectiveness of different drugs, as well as side effects and the drug’s comparison with other drugs that are similar in nature.

There are several reasons that a drug may be recalled. One reason that a drug may be recalled is because it poses the risk of health problems, such as an increased risk of heart attack, stroke, kidney failure or other serious health conditions. The second reason a drug may be recalled is because of a negative drug interaction that was not previously known, such as a bad reaction to another drug, vitamin or food. A third reason that a drug might be recalled is because of manufacturing and packaging errors, such as unsealed packaging or a contamination concern that makes the drug unsafe for patients and consumers to take.

Most of the time, a prescription drug recall is voluntary and the drug’s manufacturer works with the FDA to retrieve recalled medication and alert the public of the recall and classify its seriousness so patients and consumers understand; however, the FDA can issue a mandatory recall of a drug and require that the drug be recalled or removed from the market. In addition to the recall process, and the important protections it provides, products liability laws also protect victims harmed by a dangerous or defective drug and provides them with important legal remedies to recover damages that they should be familiar with.

Source:, “Why Drugs Get Pulled from the Market,” Accessed June 26, 2017