Birth Control Recall from Ortho-Novum Over Instructions

The makers of Ortho Novum is voluntarily recalling one lot of ORTHO -NOVUM 1/35 AND two lots of ORTHO-NOVUM 7/7/7 tablets. The pills are safe, but some lots lack appropriate instructions.

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM® 1/35 (norethindrone/ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM® 7/7/7 (norethindrone/ethinyl estradiol) Tablets to the pharmacy level. 

The patient information provided inside affected packages of ORTHO-NOVUM® does not include the appropriate instructions for the Veridate® dispenser. 

The ORTHO-NOVUM® product itself remains safe and effective for use with the appropriate dispenser instructions.  Women should continue to take the 21 "active" pills (with hormones) (peach for ORTHO-NOVUM® 1/35; white, light-peach and peach for ORTHO-NOVUM® 7/7/7) for three weeks, followed by the one week of green "reminder" pills (without hormones).

The recall affects the products below.

Consumers with ORTHO-NOVUM® product from the affected lots can access the correct instructions for the Veridate® dispenser pack at https://www.janssen.com/us/our-products and talk to their prescribing medical professional if they have any concerns.

Consumers should not stop taking the product and if they do miss a dose, they should follow the instructions included in the packet.

Photo Credit: Janssesn

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