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  1. Drug Safety and Availability

FDA warns consumers that Tydemy, a prescription oral contraceptive, may have reduced effectiveness

[August 1, 2023] FDA is warning consumers that two lots of Tydemy (drospirenone/ethinyl estradiol/levomefolate calcium), a prescription oral contraceptive (birth control pill) manufactured by Lupin Pharmaceuticals, may have reduced effectiveness due to decreased levels of ascorbic acid, an ingredient, in the product.

The affected lots (L200183 and L201560) were distributed in the U.S. from June 3, 2022, to May 31, 2023.

This potential reduction in the effectiveness of this oral contraceptive could result in unexpected pregnancy. To date, FDA has not received any reports of adverse events related to using this product.

On July 29, 2023, Lupin notified consumers about its voluntary recall of the two lots of Tydemy for patients. Lupin advises patients to continue taking their medication. Patients should immediately contact their health care provider for advice regarding an alternative contraceptive method. Lupin had previously voluntarily recalled the two lots of Tydemy at the wholesale level.

FDA encourages health care professionals and patients to report adverse events or quality problems with these or any medications to the agency’s MedWatch Adverse Event Reporting program:

  • Complete and submit the report online; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.
 
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