Oral Contraceptives Recalled

Teva Pharmaceuticals USA Inc. is recalling two lots of Nortrel oral contraceptive products because of tablet discoloration issues. According to the February 21, 2024, US Food and Drug Administration (FDA) Enforcement Report, tablets in various shades of blue are mixed in with white inert tablets.

The recall affects the following Nortrel products, which were distributed throughout the United States:

• Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets - triphasic regimen), packaged in cartons containing six 28-tablet blister cards (NDC 0555-9012-58), from lot 100040731 (Exp. 7/31/24); and
• Nortrel (norethindrone and ethinyl estradiol tablets) 0.5/35, packaged in cartons containing three 28-tablet blister cards (NDC 0555-9008-67), from lot 100042978 (Exp. 7/31/24).

Teva Pharmaceuticals USA voluntarily initiated the recall January 25, 2024. On February 12, 2024, the FDA designated the recall Class III, suggesting use of the recalled drugs is not likely to cause harm.

Nortrel is a prescription oral contraceptive indicated for the prevention of pregnancy.