Prescription Drug Recalls

The competition to develop and win approval from the U.S. Food and Drug Administration (FDA) is incredibly fierce. Drugs are frequently released without sufficient testing and later found to be unsafe.

The FDA releases hundreds of warnings and recalls for these products. Exposure to harmful prescription medications can result in life-threatening conditions, lasting medical complications, and even death.

FDA Recalls

As soon as a company learns that a medication they manufacture or distribute is potentially defective (either in its functioning or because it fails to adequately warn of a risk), they are required to notify the Food and Drug Administration, which then determines if it is necessary to issue a warning or recall. The FDA has three classes of recalls:

Class I
There is a reasonable chance that the drug will cause serious health problems or death.

Class II
There is a slight chance the drug will cause serious health problems and any issue is likely to be temporary or reversible.

Class III
There is little to no chance the drug will cause any health problem.

Patients that have used or are actively using a medication with any class of recall should speak to their doctor regarding its safety, and regardless of the severity of the risk, no medication is appropriate for FDA approval if the risk to public health outweighs the therapeutic effect of using the product or if the risks are not appropriately explained to both healthcare providers and patients.

Drugs and Medical Devices With Recent FDA Safety Warnings

Actos (type 2 diabetes)
Linked to bladder cancer, heart failure, liver failure, bone fractures, and eye problems.

Invokana (type 2 diabetes)
Reportedly causes diabetic ketoacidosis, which can lead to kidney failure, heart attack, stroke, or death.

Onglyza (type 2 diabetes)
Under investigation for causing heart failure or cardiac arrest.

Risperdal (schizophrenia, bipolar disorder, autism)
Potentially causes gynecomastia (male breast development), pancreatitis, diabetes, or movement disorders.

Other Drugs That May Have Dangerous Defects or Side Effects

Actemra (arthritis)
May lead to increased risk of heart failure, stroke, pancreatitis, lung disease or gastrointestinal perforation.

Belviq (weight loss)
May increase the risk of developing pancreatic, lung, or colorectal cancer.

Elmiron (interstitial cystitis)
Potentially causes maculopathy, also known as macular degeneration, a disease of the eye that affects vision.

Lipitor (cholesterol)
Linked to an increased risk of developing diabetes.

Pradaxa (blood thinner)
May cause internal bleeding.

Truvada (HIV prevention)
Contains an unnecessary compound called tenofovir disoproxil fumarate which may cause kidney and bone problems.

Xarelto (blood thinner)
Associated with internal bleeding, wound leakage, and potentially infections.

Baycol (cholesterol)
Allegedly causes rhabdomyolysis, a disease that damages muscle tissues.

Benicar (blood pressure)
Linked to severe gastrointestinal problems, including sprue-like enteropathy.

Injectafer (iron replacement)
May cause hypophosphatemia (low phosphate levels), which is associated with bone pain, seizures, and death.

Nexium (acid reflux, GERD, peptic ulcer disease)
Can increase the risk of developing a nutritional deficiency.

Tasigna (chemotherapy)
Has been found to cause atherosclerosis (hardening of the arteries).

Valsartan (blood pressure)
Batches of the drug may have been contaminated with NDMA, a potential carcinogen linked to many types of cancer, including liver, kidney, colorectal, stomach, and bladder cancers.

Xeljanz (arthritis)
Allegedly causes blood clots, stroke, heart attack, heart failure, or cancer.

The Duty of Drug Companies

Pharmaceutical companies have an obligation to put the safety of their customers above their own profits. However, they sometimes fall short of that responsibility by not applying the highest level of care to clinical trials, failing to adequately warn consumers of known risks, not preventing products with manufacturing defects or contaminations from reaching consumers, or delaying recalling a product that is harming patients until it becomes financially necessary to.

Some drugs should simply never have been approved in the first place, and no amount of warnings or information can make them safe for human use. When dangerous drugs cause injuries or even death, the companies that design, manufacture, test, and market them can be held responsible.

Proving a Case Against Drug Companies

In order to successfully pursue a claim against a drug company, it is necessary to keep records that the patient actually took the drug and to establish that it caused an injury.

Patients should retain any medical records connected to the drug, including:

  • Prescription orders
  • Pharmacy receipts
  • Warning labels

To prove that the drug was unreasonably dangerous, a drug injury lawyer can gather expert medical and technical testimony establishing that the medication was defective either as the result of a manufacturing defect, a failure to warn of a known risk, or that the drug never should have been approved by the FDA in the first place and that its therapeutic effects don’t outweigh the risks it poses to the public.


Patients that have been injured by a medication may be entitled to compensation, including lost earnings, payments for follow-up treatment and rehabilitation, pain and suffering, emotional distress, punitive damages, and loss of consortium (deprivation of a family relationship). Additionally, if a loved one dies as the result of a medication they took, their survivors may be entitled to bring a wrongful death action.

Statute of Limitations

In some states, patients injured by a medication have three years from the time they first were harmed (or became aware that they were harmed) to file a claim against a drug company. In most states, though, including Pennsylvania, they have only two years to bring an action, or the court will most likely dismiss their claim.

Consult With a Drug Injury Expert

Pharmaceutical companies are large and powerful organizations that aggressively defend against legal claims regarding their products. Furthermore, these cases are complex and often require in-depth analysis of medical documents and expert testimony. An experienced and knowledgeable drug injury and product liability attorney is absolutely vital to winning the compensation injured patients and their families deserve.

If you were injured by a prescription drug or other pharmaceutical product, contact Pond Lehocky Giordano for a free consultation to determine if you have a case. Call 1-800-568-7500 or fill out the form on this page.