Thousands of Tydemy birth control pills recalled amid FDA efficacy concerns

The Food and Drug Administration warned that two lots of an oral contraceptive that were recalled last week by its manufacturer may have reduced effectiveness and, as such, could result in unexpected pregnancies.

The FDA’s Tuesday announcement came after drugmaker Lupin Pharmaceuticals said it was voluntarily recalling two lots of Tydemy over concerns the product contained insufficient amounts of ascorbic acid, or vitamin C.

The deficit could “impact the effectiveness of the product” and “potentially result in unexpected pregnancy,” Lupin said in a July 28 statement.

Lupin also noted that one lot tested “high for a known impurity,” although it wasn’t clear what the impurity was.

The recall involves almost 4,200 boxes of the drug, according to FDA data.

Lupin Pharmaceuticals is the U.S. subsidiary of Lupin, an Indian generic pharmaceutical company. It received FDA approval to market Tydemy – a generic version of Bayer’s Safyral – in 2017, according to a company statement. Lupin could not be immediately reached for comment.

The two affected lots can be identified by their numbers – L200183 and L201560 – which are found on the side of their cartons.

They were distributed across the United States to wholesalers, drugstore chains, mail order pharmacies and supermarkets from June 3, 2022, to May 31 this year, according to Lupin and the FDA, which said there were no reports of “adverse events” to date.

Lupin is notifying distributors by phone and recall notification.

“Patients taking Tydemy are advised to continue taking their medication” but to immediately contact their medical provider for advice on an alternative treatment, Lupin said.

The company is also offering reimbursement to those who have purchased the pills.

The deficiency was found after a stability test, which drugmakers regularly perform to ensure their products are still good before their expiration dates.

The two affected lots had expiration dates of January 2024 and September 2024.

The FDA urged health-care professionals and patients to report adverse events or quality problems regarding the recalled pills to MedWatch, the agency’s safety reporting program.