Birth control pills voluntarily recalled as FDA warns they may have 'reduced effectiveness'
A popular type of birth control pill may have "reduced effectiveness," according to a new warning from the U.S. Food and Drug Administration.
The FDA said in a warning this week that two lots of Tydemy, a brand of prescription oral contraceptive, may have "decreased levels of ascorbic acid," which can lead to the contraceptive being less effective.
"This potential reduction in the effectiveness of this oral contraceptive could result in unexpected pregnancy," the FDA said in a statement posted online. "To date, FDA has not received any reports of adverse events related to using this product."
The two affected lots were distributed in the U.S. between June 3, 2022, and May 31, 2023, according to the FDA.
Lupin Pharmaceuticals, the company that manufactures Tydemy, issued a voluntary recall of the two affected lots of the contraceptive in late July.
The company said patients should continue taking the medication, while also immediately contacting a health care professional for "advice regarding an alternative treatment."
"To date, Lupin has received no reports of adverse events related to either recalled batches," the company said in a statement. "Regardless, 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 impacted lots of Tydemy were identified as L200183, expiring January 2024, and L201560, expiring September 2024.
The lot number can be found on the side of the product carton, according to Lupin.
Lupin said in addition to notifying customers, the company is also "notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots."
The company directed consumers and retailers with questions to call Inmar Rx Solutions, Inc. at (866) 480-8206.
Consumers can also return their products to Inmar Rx Solutions, Inc., for reimbursement, according to Lupin.
Birth control pills contain a combination of the hormones estrogen and progestin, which a woman's body already makes. These hormones override the signals from a woman's brain to her ovaries and suppress the ovulation process.
Around 14% of women ages 15 to 29 in the U.S. use oral contraception pills, according to the Centers for Disease Control and Prevention.
