Class I Recall for Oral Contraceptive

A Class I recall has been issued for two lots of Tydemy (drospirenone, ethinyl estradiol, and levomefolate calcium tablets 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg) oral contraceptives. According to the August 9, 2023, US Food and Drug Administration (FDA) Enforcement Report, the recall stems from out-of-specification test results at the 12-month stability time point.

“Specifically,” recalling firm Lupin Pharmaceuticals Inc stated in a July 29, 2023, announcement, “one lot (L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.”

The FDA warned in a follow-up announcement dated August 1, 2023, that pills in both recalled lots may have reduced effectiveness due to the decreased level of ascorbic acid.

The recall affects Tydemy, 28-tablet blister packs (NDC 68180-904-71), further packaged in a carton of three blister packs (NDC 68180-904-73), from lots L200183 (Exp 1/24) and L201560 (Exp 9/24). The product was manufactured by Lupin Limited, Pithampur, India, and distributed throughout the United States by Lupin Pharmaceuticals, Baltimore, Maryland, between June 2022 and May 2023.

Lupin Pharmaceuticals voluntarily initiated the recall June 23, 2023. The FDA designated the recall Class I on August 4, 2023. The classification, the FDA’s most urgent, warns use of the affected tablets could cause serious adverse health consequences or death.

“To date, Lupin has received no reports of adverse events related to either recalled batches,” the company stated in the July announcement. “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 a prescription estrogen-progestin oral contraceptive indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception.