Thousands of Tydemy brand birth control pills are being recalled by the Food and Drug Administration (FDA) after testing by drugmaker Lupin Pharmaceuticals revealed potential reduced effectiveness in two specific lots. The recalled batches of Tydemy pills, which are a combination prescription contraceptive, are listed on the FDA’s website and were distributed nationwide from June 2022 to May 2023. A total of 4,179 boxes, equivalent to about 350,000 tablets, have been recalled.
Individuals currently taking the recalled lots are advised to continue taking their pills but should seek an alternative contraceptive method from their doctor. Lupin Pharmaceuticals has voluntarily recalled the affected lots at the wholesale level. The decreased effectiveness of the pills is attributed to lower levels of an inactive ingredient called ascorbic acid and the presence of a known impurity. However, there have been no reports of adverse events related to the recalled batches thus far.
The FDA encourages healthcare providers and patients who have experienced issues with the tablets to report them online or by fax. The cause of the “out of specification” issue and the potential impact on other batches remain unclear. Lupin Pharmaceuticals has previously recalled batches of blood pressure medication due to impurities and has faced criticism for inadequate investigation and prevention of recurrence.
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