Lupin Pharmaceuticals, the New Jersey-based company that produces birth control pill Tydemy, is recalling two batches of the drug because they may have reduced effectiveness.
According to Lupin, the batches are being recalled because tests showed the pills had decreased levels of ascorbic acid, an inactive ingredient, and high levels of a “known impurity.”
The company said the low levels of ascorbic acid “could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy.”
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The FDA said the affected lots were distributed in the U.S. from June 3, 2022 to May 31, 2023. The FDA has not received any reports of “adverse events related to using this product,” according to the agency.
The recall affects just over TydemyTM 100 pills distributed in four blisters with a universal product code of , per the FDA:
- One blister package of 28 pills with lot number L200183, expiry of Jan. 2024 and a National Drug Code of 68180-904-71.
- Three blister packages of 28 pills each with lot number L201560, expiry of Sept. 2024 and a National Drug Code of 68180-904-73.
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Lupin said the lots were distributed in the U.S. to wholesalers, drug chains, mail order pharmacies and supermarkets.
According to the company, patients taking Tydemy are advised to “continue taking their medication and immediately contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.”
