The FDA has issued a warning about certain Tydemy birth control pills that might not work as expected and could lead to unexpected pregnancies.
The Tydemy company that makes birth control pill, is recalling two batches of the medication due to concerns about their effectiveness.
Lupin, a pharmaceutical company based in New Jersey, announced on Saturday that it is recalling these batches after tests revealed lower levels of an inactive ingredient called ascorbic acid and higher levels of a "known impurity."
According to the company's announcement, this situation could potentially affect how well the product works, possibly leading to unexpected pregnancies.
The Food and Drug Administration (FDA) also cautioned consumers on Tuesday, explaining that the reduced levels of ascorbic acid (also known as vitamin C) in Tydemy pills might make them less effective in preventing pregnancy.
However, both Lupin and the FDA emphasized that they have not received any reports of negative effects resulting from the use of these pills.
The affected batches of Tydemy pills were distributed between June 3, 2022, and May 31 of this year, and they have expiration dates of January or September 2024.
Lupin's press release recommends that individuals currently taking Tydemy should continue doing so for now. However, they should also get in touch with their pharmacist, doctor, or healthcare provider to discuss possible alternative treatments.
The company did not immediately provide more details about the impurity in the pill or how ascorbic acid is involved.
You can identify the recalled batches by checking the lot numbers on the packaging: One batch, which contains 28 pills, has the lot number L200183, while the other batch includes three packs of 28 pills and is labeled with the lot number L201560.
If you experience any issues while taking Tydemy, it's important to contact your healthcare provider. You can also report any concerns to the FDA's MedWatch Adverse Event Reporting program, as mentioned in Lupin's announcement.
Additionally, Lupin has asked pharmacies and retailers to stop distributing the affected product lots right away.