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# Lupin Recalls 2 Lots of Tydemy Contraceptive
- URL: https://www.fdaweb.com/lupin-recalls-2-lots-of-tydemy-contraceptive/
- Published: 2023-08-01T12:00:00.000Z
- Updated: 2026-09-14T18:47:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155001

Lupin Pharmaceuticals has recalled two lots of Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets 3mg/0.03mg/0.451 mg) due to out-of-specification test results at the 12-month stability time point. According to a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-2-lots-tydemytm-drospirenone-ethinyl?utm%5Fmedium=email&utm%5Fsource=govdelivery), one lot tested low for ascorbic acid (an inactive ingredient) and high for a known impurity. To date, Lupin has received no reports of adverse events related to either recalled lot.

Tydemu is an estrogen/progestin oral contraceptive indicated for use by women to prevent pregnancy and to raise folate levels in women. “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,” the notice says.