Thousands of Tydemy brand birth control pills have been recalled, the Food and Drug Administration warned Tuesday, after testing by drugmaker Lupin Pharmaceuticals found that two lots they made of the tablets might have lower effectiveness.
Recalled batches of the Tydemy pills — a combination prescription contraceptive of estrogen and progestin — are of two specific lot numbers listed on the FDA’s website.
The FDA says the products were distributed nationwide to pharmacies and supermarkets from June 2022 through May 2023.
A total of 4,179 boxes have been recalled, according to the FDA’s database, which amounts to about 350,000 tablets that might be less effective at stopping pregnancy.
People who are currently taking recalled lots of the drugs are urged to continue taking their pills but immediately seek out an alternative from their doctor.
“Lupin advises patients to continue taking their medication. Patients should immediately contact their health care provider for advice regarding an alternative contraceptive method,”the FDA said in its warning.
The agency added that Lupin has voluntarily recalled the affected lots at the wholesale level.
Why the pills might be less effective
Drugmakers routinely do what’s called “stability” testing to ensure that medications they produce are still good to use out to their expiration dates.
Lupin Pharmaceuticals says that batches of Tydemy fell short after 12 months, with too low levels of an inactive ingredient called ascorbic acid used in making the tablets, as well as too high of “a known impurity.”
“Lupin is recalling these two batches because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy,” the company said.
So far, Lupin says they have received “no reports of adverse events related to either recalled batches” from the current recall of birth control pills.
The FDA says it encourages doctors or patients who had an issue with the tablets to report it to the agency online or by fax.
It is unclear what led to the so-called “out of specification” issue, or if more batches might be affected. A spokesperson for Lupin Pharmaceuticals did not respond to a request for comment.
The recall is not the first for the drugmaker, which claims to be the “third-largest pharmaceutical company in the U.S. by prescriptions.”
Late last year, Lupin recalled batches of blood pressure medication Quinapril after finding impurities. An inspection of a facility run by the company in March turned up a range of shortcomings, including failing to run down the root causes behind several “out of specification” test results.
“Deviation investigations are not thoroughly investigated by your firms and appropriate actions are not taken to prevent recurrence,” the FDA’s inspectors wrote in that case.