Two lots of birth control pills have been recalled and now federal regulators are warning consumers that the pills may have reduced effectiveness due to a lack of one key ingredient.
Lupin Pharmaceuticals Inc., which manufactures the birth control pill Tydemy, informed customers Saturday that it was recalling two lots of the contraceptive after one batch tested low for ascorbic acid and high for a "known impurity." Lupin said inadequate amounts of ascorbic acid could potentially impact the effectiveness of the product and increase the risk of unexpected pregnancy.
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"To date, Lupin has received no reports of adverse events related to either recalled batches," the company said in an announcement posted by the Food and Drug Administration. "Regardless, Lupin is recalling these two batches."
The Tydemy lots were distributed nationwide from June 2022 through May 2023. The company said they can be identified by their lot codes — L200183 and L201560 — or their expiration dates of Jan. 2024 and Sept. 2024.
FDA
Lupin is advising patients who use Tydemy to continue taking their medication and immediately contact their health care provider for advice on finding an alternative treatment.
According to Lupin's announcement, the company is also contacting wholesalers, distributors, and retailers to discontinue distribution of all products impacted by the recall.
