Batches of Tydemy, a prescription oral contraceptive, may have reduced effectiveness, and using them may result in an unexpected pregnancy, the FDA warns.
Lupin Pharmaceuticals, the manufacturer of the pill, voluntarily recalled two lots of the medications as they may contain lower levels of ascorbic acid, an ingredient of the drug, and high levels of a "known impurity."
The affected lots, L200183 and L201560, were distributed in the United States from June 3, 2022, to May 31, 2023.
Due to potentially reduced effectiveness, using the pills could result in an unexpected pregnancy. To date, the FDA has not received any reports of adverse events related to using this product.
Lupin Pharmaceuticals advises patients to continue taking their medication and immediately contact their healthcare provider for advice regarding an alternative contraceptive method.
Tydemy is a combination oral prescription contraceptive of estrogen and progestin used to prevent pregnancy and to raise folate levels.
- FDA. FDA warns consumers that Tydemy, a prescription oral contraceptive, may have reduced effectiveness.
- FDA. Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of Tydemy™ (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) Due to Out of Specification (OOS) Results at the 12-month Stability Time Point.
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