FDA Warns that Tydemy May Have Reduced Effectiveness

Published on: 

Lower levels of an active ingredient may result in unexpected pregnancies.

On August 1, 2023, FDA warned consumers that two lots of Tydemy (drospirenone/ethinyl estradiol/levomefolate calcium), a prescription oral contraceptive manufactured by Lupin Pharmaceuticals, could be less effective because of lower levels of ascorbic acid, an active ingredient, in the product. These lots (L200183 and L201560) were dispensed in the United States from June 3, 2022, to May 31, 2023. The reduced effectiveness could result in unexpected pregnancies. FDA wrote that as of August 1, 2023, FDA “has not received any reports of adverse events related to using this product.”

On July 29, 2023, Lupin warned its consumers about its voluntary recall of the two lots of Tydemy. Lupin is notifying its wholesalers, drug chains, distributors, supermarkets, and mail order pharmacies via phone and recall notification to arrange the return of all recalled product lots. The company advised patients to keep taking their medication, but to immediately contact their health care professional about alternative contraceptive methods. Wholesalers, distributors, and retailers that have the recalled Tydemy should stop distribution of the recalled product immediately. Lupin had formerly voluntarily recalled the two lots of Tydemy at the wholesale level.


FDA wrote that it encourages healthcare professionals and patients to report any adverse events or quality issues with these or any medications to FDA’s MedWatch Adverse Event Reporting program.

Source: FDA