Birth control recalled after FDA warns of potential for reduced effectiveness

A company has voluntarily issued a recall of its oral contraceptives after the U.S. Food and Drug Administration warned of a potential for reduced effectiveness that could result in unplanned pregnancies.

Lupin Pharmaceuticals Inc. has recalled two lots of Tydemy, an estrogen/progastrin oral birth control, according to the FDA. There have been no reports of adverse events related to the recalled batches at this time.

However, the company is recalling the batches due to a significant reduction in the amount of an inactive ingredient that could impact the effectiveness of the contraceptive, according to the FDA.

Tydemy, an oral contraceptive, is being recalled due to concerns of reduced effectiveness that could lead to unplanned pregnancies. Photo courtesy the U.S. Food an Drug Administration.

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Anyone experiencing adverse reactions should report it to the FDA’s MedWatch Adverse Event Reporting program online or by calling 1-800-332-1088.

The recalled lot numbers of L200183 and L201560, which can be found on the side of the carton. The first lot has an expiration date of January 2024 and the second lot expires in September 2024. Both have the UPC code 368180904731 and were distributed from June 2022 to May 2023.

The company advises patients on Tydemy continue taking their medication but immediately contact their pharmacist, doctor or medical provider for advice about an alternative treatment.

Lupin is notifying wholesalers, distributors, supermarkets and mail-order and chain pharmacies and arranging for the products to be returned. Retailers with the recalled lots should immediately discount distributing the product.

Anyone with questions should call Inmar Rx Solutions, Inc. at 866-480-8206 from 9 a.m. to 5 p.m. on weekdays.

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