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FDA Warns Consumers of Reduced Effectiveness of Contraceptive Pill Tydemy Due to Low Levels of Ascorbic Acid

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Key takeaways:

  • The Food and Drug Administration (FDA) has issued a warning about two batches of the contraceptive pill Tydemy, which may have reduced effectiveness and could result in unexpected pregnancy.
  • The recalled Tydemy birth control products are marked with national drug codes (abbreviated NDC) reading 68180-904-71 or 68180-904-73.
  • The FDA is reminding consumers to always read the label of any medication they take and to contact their health care provider if they have any questions or concerns.

The Food and Drug Administration (FDA) has issued a warning to consumers about two batches of the contraceptive pill Tydemy, which may have reduced effectiveness and could result in unexpected pregnancy.

The pharmaceutical company Lupin, based in New Jersey, announced Saturday that it was recalling the batches after tests showed the pills had decreased levels of ascorbic acid, an inactive ingredient, and high levels of a “known impurity.”

The recalled Tydemy birth control products are marked with national drug codes (abbreviated NDC) reading 68180-904-71 or 68180-904-73.

The FDA warned that the low levels of ascorbic acid in the Tydemy pills could reduce their effectiveness in preventing pregnancy. Anyone taking the pills is advised to continue but to also immediately contact their health care provider for advice regarding an alternative contraceptive method.

The agency said it has not yet received any reports of adverse events related to the recalled batches. Lupin is asking consumers to return any unused pills from the recalled batches to their pharmacy.

The FDA is reminding consumers to always read the label of any medication they take and to contact their health care provider if they have any questions or concerns.

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