FDA Issues Warning and Voluntary Recall of Birth Control Pills Due to Potential ‘Reduced Effectiveness’

The U.S. Food and Drug Administration has warned about a popular type of birth control pill that may have “reduced effectiveness.”

Earlier this week, the FDA warned that two batches of Tydemy, a prescribed oral contraceptive, might have lower ascorbic acid levels, making the contraceptive less effective.

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

The FDA noted that the two affected lots were distributed in the U.S. between June 3, 2022, and May 31, 2023.  Lupin Pharmaceuticals, the manufacturer of Tydemy, voluntarily recalled these lots in late July.

The manufacturer advised patients to keep taking the medication and consult a healthcare provider for guidance on alternative treatments.

“To date, Lupin has received no reports of adverse events related to either recalled batches,” the company said.  “Regardless, Lupin is recalling these two batches because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product, which could potentially result in an unexpected pregnancy.”