NEW YORK (AP) — Federal regulators are warning consumers that now-recalled lots of the Tydemy birth control pill “may have reduced effectiveness” due to decreased levels of a key ingredient of the product.

Lupin Pharmaceuticals, which manufactures Tydemy, notified customers on Saturday that it was voluntarily recalling two batches of the oral contraceptive — after one lot tested low for ascorbic acid and high “for a known impurity.”

Inadequate ascorbic acid “could potentially impact the effectiveness” of the birth control, Lupin said in a company announcement published by the Food and Drug Administration, which could result in unexpected pregnancy.

In an addition alert published by the FDA on Tuesday, regulators confirmed that no reports of adverse effects related to the recalled lots of Tydemy had been reported to date.

ProductLot numberExpiryNational Drug CodeUPCDistribution dates
TydemyTML200183Jan. 202468180-904-71
(1 Blister of 28 tablets each)
368180904731June 2022 to May 2023

TydemyTML201560Sep. 202468180-904-71
(1 Blister of 28 tablets each)
368180904731June 2022 to May 2023