A Widely-Used Drug for Cancer, Seizures, and More Has Been Recalled Nationwide by the FDA

Giving your immune system a boost—especially as cold and flu season begins to arrive—might be top of mind with the holidays also right around the corner. But for millions of Americans, suppressing the immune system might actually be what’s needed to better navigate certain health conditions, including cancer. But one medication, trusted for its availability to help patients experiencing everything from breast cancer to epilepsy, is now named a nationwide recall notice.

In an announcement updated on October 29, the U.S. Food and Drug Administration (FDA) alerted the public regarding the recall of 11,391 cartons of a multi-purpose drug known as Everolimus tablets, citing “failed impurities.” Specifically, the agency lists “Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.” as the recalling reason.

According to the Mayo Clinic , the medication may be known by brand names such as Afinitor or Zortress. With a range of important applications, the clinic’s experts say the drug is most frequently used:

• To treat cancerous and noncancerous tumors of the kidneys, breast, brain, pancreas, stomach, bowels, or lungs
• To treat noncancerous tumors in those body parts
• To treat partial-onset seizures (epilepsy) in those with tuberous sclerosis complex (TSC)
• To prevent the body from rejecting kidney or liver transplants 

As explained by the National Cancer Institute, Everolimus works by blocking the activity of an enzyme called mTOR, which can then stop “the growth of cancer cells and the growth of blood vessels that support tumor growth.” Additionally, it can suppress the immune system, a key for organ transplant recipients to prevent their bodies from rejecting the transplanted organ. 

The FDA provided the following product details:

Everolimus Tablets 5 mg

• Quantity: 6,655 cartons
• NDC (National Drug Code): 49884-125-91
• Lot Number and Expiration Dates:
  • Lot Number: 550184901, Exp. MAR-26
  • Lot Number: 550185001, Exp. MAR-26
  • Lot Number: 550189901, Exp. APR-26
  • Lot Number: 550190001, Exp. APR-26
  • Lot Number: 550203901, Exp. JUL-26
  • Lot Number: 550205601, Exp. JUL-26

Everolimus Tablets 7.5 mg

• Quantity: 1,866 cartons
• NDC (National Drug Code): 49884-127-91
• Lot Number and Expiration Dates:
  • Lot Number: 550167301, Exp. NOV-25
  • Lot Number: 550167401, Exp. NOV-25
  • Lot Number: 550185101, Exp. MAR-26
  • Lot Number: 550205701, Exp. JUL-26

Everolimus Tablets 10 mg

• Quantity: 935 cartons
• NDC (National Drug Code): 49884-128-91
• Lot Number and Expiration Dates:
  • Lot 550162801, Exp. NOV-25
  • Lot 550169801, Exp. JAN-26

Everolimus Tablets 2.5 mg

• Quantity: 2,035 cartons
• NDC (National Drug Code): 49884-119-91
• Lot Number and Expiration Dates:
  • Lot 550172201, Exp. JAN-26
  • Lot 550184801, Exp. MAR-26
  • Lot 550204001, Exp. JUL-26

Distributed by Endo USA, Inc., located near Philadephia, Pennsylvania, and manufactured by Par Pharmaceutical of Chestnut Ridge, New York, the affected meds were packaged in 28-tablet cartons containing four blister packs of seven tablets each. 

In an online guidance, the FDA notes that an investigation is required “whenever an [out of specification] test result is obtained.” The federal health authority has assigned the incident, first initiated on October 10, as a Class III risk level—the lowest in a three tier system used to communicate health concerns to the public. This means that the agency has determined that the recall is “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.” 

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