Safety Report: Lupin Tydemy oral contraceptive - recalled due to Out of Specification Results, USA

United States

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. The lots were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. To date, Lupin has received no reports of adverse events related to either recalled batches. 

Regardless, Lupin is recalling these two batches because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy. 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.

The TydemyTM 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. The recalled lots are: L200183, Expiry Jan. 2024 and L200183, Expiry Sep. 2024. NDC: 68180-904-71 (1 Blister of 28 tablets each), 68180-904-73 (3 Blister of 28 tablets each). UPC: 368180904731. Distribution Dates: June 2022 to May 2023.

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.

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.

Wholesalers, distributors and retailers that have Tydemy that is being recalled should discontinue distribution of the recalled product lots immediately.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Lupin Pharmaceuticals, Inc.
Brand name: Lupin Pharmaceuticals, Inc.
Product recalled: Tydemy oral contraceptive
Reason of the recall: Out of Specification Results
FDA Recall date: July 31, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-2-lots-tydemytm-drospirenone-ethinyl