FDA recalls 350,000 Tydemy birth control pills sold since last June because they might not work

Hundreds of thousands of birth control pills were recalled after the manufacturer found they were ineffective, potentially resulting in an unplanned pregnancy.

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

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

Lupin also said they have determined through testing of specific lots of pills not just low levels of vitamin C, also known as ascorbic acid, but also high levels of a ‘known impurity’, the name for which was not included in the recall announcement.

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

The recall announced on July 29 was a result of the company’s routine stability testing, which drugmakers conduct in order the make sure their medications are still good through their intended shelf life. 

The two lots that were recalled had expiration dates of January 2024 and September 2024. Prior to the recall, testing of those batches after 12 months revealed deficient levels of ascorbic acid, an inactive ingredient in the pills that helps improve long-term stability. 

In announcing the recall, the drugmaker said: ‘To date, Lupin has received no reports of adverse events related to either recalled batches. 

‘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 two affected lots are identified by a unique series of numbers printed on the side of the packaging – 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. 

Lupin added: ‘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.

‘Wholesalers, distributors and retailers that have Tydemy that is being recalled should discontinue distribution of the recalled product lots immediately.’