Lupin Pharmaceuticals has recalled two batches of the oral birth control Tydemy due to reduced effectiveness that may result in unexpected pregnancies for users.
The FDA said that the pills were voluntarily recalled after manufacturers realized that the oral contraception contained a decreased level of ascorbic acid, an ingredient in the product, and high levels of a “known impurity.”
The company said the low levels of ascorbic acid “could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy.” However, the FDA noted that they have not received any reports of “adverse events related to using this product.”
The recalled batches of the Tydemy pills, a combination prescription contraceptive of estrogen and progestin, are lots L200183 and L201560 and were distributed by pharmacies across the U.S. from June 3, 2022, to May 31, 2023. Consumers can find the lot number on the side of the label.
According to the FDA, a total of 4,179 boxes of the oral birth control have been recalled.
People who are currently taking recalled lots of the drugs are urged to continue taking their pills but immediately seek out an alternative from their doctor.
This is not Lupin Pharmaceuticals’ first voluntary recall.
In December of last year, Lupin recalled one batch of 20-milligram Quinapril Tablets USP and three batches of 40-milligram Quinapril Tablets USP due to the potential presence of a nitrosamine impurity.