FDA Issues Warning About 2 Batches of Birth Control Pills

Some Tydemy pills may not prevent pregnancy, FDA says after company issues recall

Birth control pills in Centreville, Md., on July 6, 2022. Jim Watson/AFP via Getty Images

The U.S. Food and Drug Administration is warning consumers that two batches of the prescription birth control pill Tydemy may not be effective and could result in unexpected pregnancy.

The warning on Aug. 1 comes after Lupin Pharmaceuticals, the manufacturer of the Tydemy pills, issued a voluntary recall on July 29 over the same concerns.

Testing of the two batches of pills suggested they had decreased levels of absorbic acid, the company said.

“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,” Lupin said in its announcement.

It pointed out that as of July 29, it “has received no reports of adverse events related to either recalled batches.” The FDA’s statement similar noted it “has not received any reports of adverse events related to using this product.”

Tydemy oral contraceptive product. Lupin Pharmaceuticals via U.S. Good and Drug Administration

The birth control pills are “indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception,” according to Lupin.

“Patients taking Tydemy are advised to continue taking their medication and immediately contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment,” the company stated.

The lots in the recall—L200183 and L201560—were distributed between June 3, 2022, and May 31, 2023. They have expiration dates of January 2024 or September 2024.

“Wholesalers, distributors and retailers that have Tydemy that is being recalled should discontinue distribution of the recalled product lots immediately,” the recall announcement reads.

Recalled lots can be returned to Inmar Rx Solutions for reimbursement. Those with questions about the recall should contact Inmar Rx Solutions at [phone].

Oral Contraceptives

Oral contraceptives, the most common form of birth control in the United States, have been used by tens of millions of women since the 1960s, with all of them requiring a prescription—until mid-July when the FDA approved the first over-the-counter birth control pill—Perrigo’s once-a-day Opill. There are no age restrictions.

The agency said it approved the pill in part because it may reduce the number of “unintended pregnancies.”

Over the year, there have been numerous studies in the United States and other countries suggesting that increased access to contraception such as birth-control pills can lead to a decline in fertility and birth rates.

U.S. birth rates have plummeted over the past five decades or so, according to federal officials in an early 2023 report that surveyed tens of thousands of people. “Between 1976 and 2018, the mean number of children ever born per woman declined, from three children to two,” the report (pdf) said.

Recent research published in June this year suggests that women who use oral contraceptives are at higher risk of depression, with teenage users having a 130 percent higher chance of showing symptoms of depression.

The study, published in the journal Epidemiology and Psychiatric Science, noted that even after teenage users stopped using the pill, an increased incidence of depression was observed. This was not seen among adults who used the contraceptive pills.

In addition to depression, contraceptive pill use may also shrink brains, according to a small study presented in late 2019. In the study of 50 healthy women, researchers examined how extrinsic sex hormones like birth control pills would affect the brain’s gray matter. The researchers found a “dramatic difference” in the size of the hypothalamic brain structures between the 21 women taking the contraceptive pills and the rest of the 50 those who did not.

Dr. Michael L. Lipton, the head of the research team, noted their analyses “confirm, for the first time, that current oral contraceptive pill usage is associated with smaller hypothalamic volume.”

The pill can also alter how women feel about the men they have sexual contact with. In a May 2016 study published in the journal Social Cognitive and Affective Neuroscience, researchers concluded that hormonal contraceptive pills suppressed the oxytocin-induced “brain reward responses” of women toward the face of their romantic partner.

Earlier research from the same team had shown that among men, the release of oxytocin made them perceive their female partners as more attractive and triggered higher activity in the neural reward regions.

The exact opposite was found to be happening in the brains of women who took hormonal birth control pills, per the study.

Jack Phillips and Naveen Athrappully contributed to this report.