Was Your Transplant Medication Safe? The Disturbing Truth About Tacrolimus and the FDA’s Hidden Exemptions

When a patient receives a life-saving kidney transplant, they rely on immunosuppressive medications like tacrolimus to prevent their body from rejecting the organ. These drugs are not optional—they are critical. But what happens when the very drug meant to protect a transplant patient may have contributed to the failure of their new organ?

According to a recent Pro Publica Investigation, that is the unsettling reality facing Joe DeMayo, a transplant recipient who was prescribed generic tacrolimus manufactured by Intas Pharmaceuticals. Despite faithfully taking the drug as directed, his donated kidney began to fail much earlier than expected. What DeMayo didn’t know—and what thousands of patients across the country likely didn’t know—is that the FDA had found serious manufacturing violations at the Indian factory where his medication was produced, including the manipulation of drug-testing records.

As New York medical malpractice attorneys, we are deeply concerned by the implications of this case—not only for DeMayo, but for the many transplant patients who trust that the drugs they take are both safe and effective.

The FDA’s Troubling Practice of Silent Exemptions

In 2023, the FDA banned the Intas factory from exporting drugs to the U.S. after inspectors discovered falsified records and contamination concerns. But under a little-known exemption policy, the FDA allowed some medications—including tacrolimus—to continue being shipped into the United States to avoid potential drug shortages.

The public was not notified. Neither were doctors or patients.

Worse, independent lab testing conducted by Valisure found that DeMayo’s tacrolimus capsules not only varied in dosage, but also dissolved much faster than brand-name equivalents—raising the possibility of toxic exposure and long-term kidney damage. This finding echoed concerns published on the FDA’s own website, which warned that such dissolution differences could lead to inferior therapeutic effects and increased toxicity.

Are Patients Being Put at Risk Without Their Knowledge?

It is not clear whether DeMayo’s kidney failure was directly caused by the drug. But what is clear is that he, like so many others, was never informed that the medication he was prescribed had been manufactured at a facility under serious FDA scrutiny.

In medical malpractice law, patients have the right to be informed about the risks associated with their care. If doctors, hospitals, or government regulators fail to disclose known dangers—or continue prescribing or distributing defective drugs despite known quality issues—there may be grounds for a lawsuit.

Holding Drug Manufacturers and Regulators Accountable

This is not a one-time incident. According to ProPublica, the FDA has quietly allowed over 150 drugs from banned factories into the U.S. over the last 12 years. Patients often have no idea that their medications come from facilities with a history of violations.

If you are a transplant patient or have been prescribed tacrolimus and have experienced adverse side effects, declining kidney function, or organ rejection, you may have legal recourse. The attorneys at Gair, Gair, Conason, Rubinowitz, Bloom, Hershenhorn, Steigman & Mackauf have represented victims of dangerous drugs and pharmaceutical negligence for decades. We work with medical experts to determine whether a defective or poorly manufactured medication contributed to your injuries.

Contact Us

If you believe your health was compromised by a defective medication, call 212-943-1090 or fill out a form on our website for a confidential consultation. We represent victims of pharmaceutical negligence throughout New York and have secured record-setting verdicts in product liability and medical malpractice cases.