FDA is recalling 350,000 Tydemy birth control pills sold since last June because they may not work

Hundreds of thousands of birth control pills were recalled after the manufacturer found them to be ineffective, possibly resulting in an unplanned pregnancy.

The Food and Drug Administration announced this week’s voluntary recall of combined estrogen and progestin pills from India-based Lupine Pharmaceuticals after it was found that the pills contained insufficient levels of inactive vitamin C, which could impact their ability to to prevent pregnancy.

The company’s decision to issue the recall affects a total of 4,179 cartons of daily pills, amounting to approximately 350,000 in total. They were distributed nationwide to pharmacies and supermarkets from June 2022 to May 2023.

Lupine also said that by testing specific batches of pills, they found not only low levels of vitamin C, also known as ascorbic acid, but also high levels of a “known impurity,” the name of which was not included in the recall notice.

The company advised patients to continue taking the drugs for now, but to contact their doctor immediately about trying an alternative drug, such as the progestin-only ‘minipill’.

The recall announced on July 29 was the result of the company’s routine stability testing, which drugmakers perform to ensure their drugs are still good for their intended shelf life.

The two batches that were recalled had expiration dates of January 2024 and September 2024. Prior to the recall, 12-month testing of those batches showed a deficiency of ascorbic acid, an inactive ingredient in the pills that helps improve long-term stability.

In announcing the recall, the drugmaker saidTo date, Lupine has not received any adverse event reports related to either recalled lot.

“Nevertheless, Lupine is recalling these two batches because if there were to be a significant reduction in the amount of inactive content (ascorbic acid), this could potentially affect the effectiveness of the product, potentially leading to unexpected pregnancy.”

The two parties involved are identified by a unique series of numbers printed on the side of the package: L200183 and L201560.

The company has contacted drug wholesalers, distributors, pharmacy chains, mail-order pharmacies and supermarkets by phone and is arranging a method for returning all recalled product lots.

Lupine added: ‘Patients taking Tydemy are advised to continue their medication and to contact their pharmacist, doctor or healthcare provider immediately for advice on alternative treatment.

“Wholesalers, distributors and retailers who have Tydemy that is being recalled should immediately stop distributing the recalled product lots.”

There are two main types of contraceptive pills for women: combined oral contraceptives, also known as “the pill,” and a progestin-only pill. Both are prescribed by a doctor and taken at the same time each day, with women advised to take a week break each month.

The combined pill contains an artificial version of the female hormones estrogen and progestogen, which are produced naturally in the ovaries.

It works by preventing the ovaries from releasing an egg each month and thickening the mucus in the cervix, making it more difficult for sperm to enter the uterus and reach an egg.

About 73 million American women are in their reproductive years, which typically range from age 15 to 49, and the vast majority of them use some form of birth control, such as birth control pills, condoms, or contraceptives.

There are approximately 73 million American women of childbearing age ranging from 15 to 49, and the majority of them use at least one form of birth control, including hormonal oral contraceptives, condoms, and an intrauterine device (IUD).

Estimates from the Centers for Disease Control and Prevention show that from 2015 to 2017, nearly 65 percent of women used birth control in some form.