Ortho-Novum Birth Control Recall Issued

The popular Ortho-Novum birth control has been voluntarily recalled by Janssen Pharmaceuticals, Inc., a private Johnson & Johnson (JNJ) company. The recall affects one lot of Ortho-Novum 1/35 tablets and two lots of Ortho-Novum 7/7/7 tablets because they contained inaccurate Veridate dispenser instructions inside the packaging.

Users of the Ortho-Novum birth control can continue to use the product with the appropriate dispenser instructions as it is still safe and effective, the company said.

Without the improper instructions provided with the affected Ortho-Novum birth control, users could run the risk of taking the pills in the wrong order. This could mean that women would take an inactive “reminder” pill instead of an active pill, which could potentially lead to pregnancy or breakthrough bleeding.

According to Janssen, women should continue taking the 21 Ortho-Novum active pills that contain hormones and are peach colored for Ortho-Novum 1/35 and white, light peach, and peach colored for Ortho-Novum 7/7/7. The pills should be taken for three weeks and then be followed by one full week of green “reminder” pills.

The Ortho-Novum 1/35 lot affected by the recall is 18BM114. It has a carton number of 50458-176-06 and a pouch number of 50458-176-28. The expiration date of the lot will read 03/2020.

The Ortho-Novum 7/7/7 lots affected include 18CM120, which has a carton number of 50458-178-06 and a pouch number of 50458-178-28. The expiration date for the lot reads 03/2020.

Also, affected by the recall is Ortho-Novum 7/7/7 with a lot number of 18BM110 and a carton and pouch number of 50458-178-12. The expiration date on the birth control reads 03/2020.

The recall only affects Ortho-Novum birth control sold and distributed in the U.S. and listed above. These retailers have been notified of the recall. Janssen has also notified the U.S. Food and Drug Administration (FDA) of the recall.

To receive the correct Veridate dispenser instructions for the Ortho-Novum birth control lots affected, follow this link. Janssen urges consumers that have concerns to speak to their prescribing physician and has warned users not to stop taking the product. Consumers can also contact Janssen directly at 1-800-526-7736 (1-800-JANSSEN) from 9 a.m. to 8 p.m. Monday through Friday EST.

Adverse effects of the birth control can be reported online, by mail, or by fax to the FDA's MedWatch Adverse Event Reporting program.