--- title: "Lupin Pharmaceuticals, Inc.: Tydemy oral contraceptive — FDA announcement Jul 31, 2023 | Is It on Recall" description: "Out of Specification Results" url: https://isitonrecall.com/recall/fdapress-0d8ce56903de9c90-lupin-pharmaceuticals-inc-tydemy-oral-contraceptive/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA company announcement # Lupin Pharmaceuticals, Inc.: Tydemy oral contraceptive — FDA announcement Jul 31, 2023 Reported terminated A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing. Source date Jul 31, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Tydemy oral contraceptive - **Reason**: Out of Specification Results - **Classification**: Not supplied - **Recalling firm**: Lupin Pharmaceuticals, Inc. - **Quantity**: Not supplied - **Agency-reported status**: Terminated in FDA listing - **Source record identifier**: 0d8ce56903de9c90 [Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-2-lots-tydemytm-drospirenone-ethinyl) ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Baltimore, Maryland, July 28, 2023: Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at the 12-month stability time point. Specifically, one lot (L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.; Tydemy is estrogen/progestin oral contraceptive (COC) indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception. Tydemy is packaged in 28’s blister. One such blister was then packed in a pouch along with one printed sleeve, one pack insert (with day label) and one oxygen absorber (Stabilox) sachet. The three pouches were packed in one carton.; Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (866) 480-8206 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the carton. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.; Product \| Lot No \| Expiry \| NDC(s) \| UPC \| Distribution Dates; TydemyTM \| L200183 \| Jan. 2024 \| 68180-904-71 (1 Blister of 28 tablets each) 68180-904-73 (3 Blister of 28 tablets each) \| 368180904731 \| June 2022 to May 2023; L201560 \| Sep. 2024 | Match all identifying details in the current notice. A brand name alone is not enough. ## Product tables from the announcement These identifying details come from the company announcement posted by FDA. Check the current notice for revisions. **FDA company announcement, table 1** | Product | Lot No | Expiry | NDC(s) | UPC | Distribution Dates | | --- | --- | --- | --- | --- | --- | | TydemyTM | L200183 | Jan. 2024 | 68180-904-71 (1 Blister of 28 tablets each) 68180-904-73 (3 Blister of 28 tablets each) | 368180904731 | June 2022 to May 2023 | | TydemyTM | L201560 | Sep. 2024 | 68180-904-71 (1 Blister of 28 tablets each) 68180-904-73 (3 Blister of 28 tablets each) | 368180904731 | June 2022 to May 2023 | Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-2-lots-tydemytm-drospirenone-ethinyl). ## Distribution Not supplied No US distribution state could be established from this record. Check the official notice. ## Dates in the source - **Fda listing date**: Jul 31, 2023 - **Company announcement date**: Jul 29, 2023 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next 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. Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (866) 480-8206 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the carton. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. [Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-2-lots-tydemytm-drospirenone-ethinyl) ## Before changing a medicine Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine. Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do) ## Related records [Medications records](https://isitonrecall.com/category/medications/) [Lupin Pharmaceuticals Inc. records](https://isitonrecall.com/brand/lupin-pharmaceuticals-inc/)