Tydemy Recall Issued Due to Risk Birth Control Pills May Not Be Effective

Women taking the recalled Tydemy pills to prevent pregnancy should to continue to do so until their doctor can provide them with an alternative form of birth control, according to the recall notice

Lupin Pharmaceuticals is recalling two lots of their Tydemy birth control pills, warning the pills contain ingredients that do not meet necessary specifications, which could expose users to an increased risk of unplanned pregnancy.

The U.S. Food and Drug Administration (FDA) announced the Tydemy recall on August 1, indicating the combination birth control pills contain low levels of ascorbic acid and high levels of a known impurity, which could reduce their overall effectiveness.

Tydemy is a prescription oral contraceptive pill that uses a combination of estrogen and progestin hormones to prevent pregnancy, as well as to help increase folate, or vitamin b levels in women who are planning a future pregnancy.

The low levels of ascorbic acid, more commonly known as vitamin C, and high levels of a known impurity, which was unnamed in the recall notice, were discovered when the pills were put through an ingredient stability test. While vitamin C is an inactive ingredient in Tydemy birth control pills, the manufacturer warns the low levels could impede the effectiveness of the pills in preventing pregnancy.

The recall includes two lots of Tydemy birth control pills distributed with product code 368180904731 from June 2022 until May 2023. The defective batches were dispensed in single blister packets of 28 tablets each with lot number L200183 and an expiration date of January 2024, as well as in cartons containing three blister packets of 28 tablets each with lot number L201560 and an expiration date of September 2024.

Customers who are currently taking the recalled drugs are being advised to continue taking their medications, and to contact their health care provider or pharmacist for guidance on implementing an alternative contraceptive method.

The FDA is also encouraging consumers to report any adverse side effects, reactions, or quality issues they have experienced while taking the medications to the MedWatch Adverse Event Reporting program using the online reporting form.