Lupin Pharmaceuticals Inc., Lupin's US subsidiary, has withdrawn two batches of Tydemy, an oral contraceptive, due to 'out of specification' outcomes at the 12-month stability check point. 

The recall is voluntary due to a considerable decrease in the amount of inactive content (ascorbic acid) in the product and went into effect following Lupin's notification to the US Food and Drug Administration on July 29. 

Tydemy lots that were impacted were distributed between June 3, 2022 and May 31, 2023.