Birth control pill recall by FDA in US

FDA Warns of Birth Control Pill Recall Due to Potential Reduced Effectiveness

On August 1, the U.S. Food & Drug Administration issued a recall for thousands of Tydemy birth control pills due to concerns about their effectiveness, which could potentially result in “unexpected” pregnancies.
The recall specifically applies to two lots of the Tydemy pill, a prescription oral contraceptive produced by Lupin Pharmaceuticals. The FDA stated that these lots might have reduced effectiveness because of lower levels of ascorbic acid, also known as vitamin C, which is one of the ingredients in the product.
Tydemy is a combination hormone medication containing drospirenone (a progestin hormone), ethinyl estradiol (an estrogen), and levomefolate calcium, as specified by the FDA.
Lupin voluntarily initiated the recall on July 29 and advised customers to continue taking their medication while promptly consulting with their pharmacist, physician, or medical provider to discuss alternative contraceptive methods. The company cited the reduced level of ascorbic acid and the presence of a “known impurity” as reasons for the recall, though the specific impurity was not disclosed.
Although the FDA has cautioned that the decreased levels of ascorbic acid in the two affected lots could potentially lead to “unexpected pregnancy,” they clarified that as of now, they have not received any reports of “adverse events” related to the use of the Tydemy pill. Lupin Pharmaceuticals also confirmed the absence of adverse event reports concerning their product.

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