TOPEKA (KSNT) — National officials are warning the public of a recall involving two lots of contraceptive over concerns of an increased risk of pregnancy while using the product.
The U.S. Food and Drug Administration (FDA) announced Monday that Lupin Pharmaceuticals Inc. is recalling Tydemy, an estrogen/progestin oral contraceptive used to prevent pregnancy.
Tydemy was recalled due to out-of-specification results and testing low for ascorbic acid and high for a known impurity, according to the FDA.
Lots of Tydemy were distributed nationwide to U.S. wholesalers, drug chains, mail-order pharmacies and supermarkets, according to the FDA.
| Product | Lot number | Expiry | National Drug Code | UPC | Distribution dates |
| TydemyTM | L200183 | Jan. 2024 | 68180-904-71 (1 Blister of 28 tablets each) | 368180904731 | June 2022 to May 2023 |
| TydemyTM | L201560 | Sep. 2024 | 68180-904-71 (1 Blister of 28 tablets each) | 368180904731 | June 2022 to May 2023 |
Patients taking Tydemy are advised to stop taking the medication and contact a pharmacist, physician or medical provider for alternative treatment. There are currently no reports of adverse events being related to the recalled batches. Lupin is still recalling the batches because the amount of ascorbic acid could impact the product’s effectiveness, according to the FDA.
Anyone with questions regarding the recall is asked to contact Inmar Rx Solutions, Inc. at 866-480-8206 on weekdays from 9 a.m. to 6 p.m. EST. Any adverse reactions can be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mail by requesting a form at 1-800-322-1088 or by fax at 1-800-FDA-0178.