Signage is visible outside the U.S. Food and Drug Administration headquarters in White Oak, Maryland, on Aug. 29, 2020.
Andrew Kelly | Reuters
The U.S. Food and Drug Administration (FDA) has issued a warning regarding the potential ineffectiveness of certain Tydemy birth control pills. This comes after the manufacturer recalled two batches of the medication that were distributed in the United States.
The FDA stated that these specific pills could lead to unexpected pregnancies. However, the agency has not received any reports of adverse events associated with Tydemy thus far.
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The manufacturer, Lupin Pharmaceuticals, initiated a voluntary recall of two batches of Tydemy on July 29. These batches were distributed in the U.S. between June 3, 2022, and May 31, 2023.
Last week, Lupin Pharmaceuticals issued a statement explaining the recall. The statement indicated that one batch of pills had low levels of ascorbic acid and a high level of a known impurity. According to Lupin, a significant reduction in ascorbic acid can impact the effectiveness of the product.
Lupin is actively informing wholesalers, distributors, drug chains, and supermarkets about the issue and taking steps to remove the affected pills from store shelves. The company advises any store, distributor, or wholesaler that has the affected pills in stock to immediately halt distribution.
The ineffective batches of Tydemy can be identified by the lot numbers L200183 and L201560.
Lupin recommends that patients continue taking their medication but consult with their doctor promptly regarding alternative forms of contraception.
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