NATIONWIDE — Birth control pill Ortho-Novum has been recalled over incorrect dispenser instructions, according to the Food and Drug Administration.

  • Janssen recalls Ortho-Novum birth control pill
  • Three lots affected, says the company
  • MORE INFO: Visit the FDA's website

Janssen Pharmaceuticals issued the voluntary recall for one lot of the Ortho-Novum 1/35 tablets (norethindrone/ethinyl estradiol) and two lots of Ortho-Novum 7/7/7 tablets (norethindrone/ethinyl estradiol).

The following are the three lots recalled:

  • Ortho-Novum 1/35; carton number 50458-176-06; pouch number 50458-176-28; lot number 18BM114; expiration date: March 2020
  • Ortho-Novum 7/7/7; carton number 50458-178-06; pouch number 50458-178-28; lot number 18CM120; expiration date: March 2020
  • Ortho-Novum 7/7/7; carton number 50458-178-12; pouch number 50458-178-12; lot number 18BM110; expiration date: March 2020

The company in a press release said the patient information inside the affected packages do not include the appropriate instructions for the “Veridate dispenser.”

Taking the pills in the incorrect order could result in unplanned pregnancy or breakthrough bleeding, according to the company.

Janssen emphasized in its release that the Ortho-Novum product itself is safe and effective when used following the appropriate dispenser instructions. The recall also only affects the United States.

For more information on the recall, visit the FDA's website.

For additional questions, contact Janssen at 1-800-526-7736 Monday through Friday from 9 a.m. to 8 p.m. ET.

50458-178-12
50458-178-12
50458-178-12