Drug Recall: ORTHO-NOVUM - MedWaste Management Drug Recall: ORTHO-NOVUM - MedWaste Management

Medical Waste and the Healthcare Industry Blog

Stay tuned to our blog for timely updates and insights into the ever-evolving landscape of medical waste news and developments.

woman with pill

Drug Recall: ORTHO-NOVUM

Janssen Pharmaceuticals has issued a voluntary recall for three lots of ORTHO-NOVUM tablets. The packages had the wrong instructions for the Veridate® dispenser included in them.

Only three lots of ORTHO-NOVUM were affected: ORTHO-NOVUM® 1/35, ORTHO-NOVUM® 7/7/7, ORTHO-NOVUM® 7/7/7. The FDA website has detailed information about the specific lots.

ORTHO-NOVUM® (norethindrone/ethinyl estradiol) is a contraceptive. It is used as birth control, to prevent pregnancy, and at times used as hormonal treatment for severe acne.

ORTHO-NOVUM® pill packs contain 28 pills with active medication. 21 have active medication/hormones, and 7 pills are inert reminder pills.

The potential risk of taking ORTHO-NOVUM® without the appropriate instructions for correct use of the Veridate® dispenser pack is that the pills would be taken in the incorrect order.

That could be harmless and still provide an adequate dose. However, the other risk is that the inactive “reminder” pill would be taken on days that the active pill is necessary. This could lead to breakthrough bleeding and, in a case of active ovulation, could lead to unintended pregnancy.

The lots with the inaccurate patient instructions were distributed only in the United States, to wholesalers, distributors, and pharmacies. Janssen Pharmaceuticals have already sent out letters and notifications to return the affected products.

Consumers with ORTHO-NOVUM® product from the affected lots can get the correct instructions for the Veridate® dispenser pack at https://www.janssen.com/us/our-products. If they have any concerns about their treatment program, they can talk to their prescribing medical professional. Consumers should not stop taking the product and if they do miss a dose, they should follow the instructions included in the packet for missing a dose.

The ORTHO-NOVUM® product itself remains safe and will be effective with the appropriate dispenser instructions. 

No other ORTHO® contraceptive products beyond those three lots are impacted by this recall action.

Any questions regarding this recall can be addressed to Janssen Pharmaceuticals by phone: 1-800-526-7736 (1-800-JANSSEN) Monday through Friday from 9:00 am to 8:00 pm ET. Consumers should contact their healthcare provider if they have experienced any problems that might be related to using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.


We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management brings great benefit to the healthcare industry and the general public alike. We publish this blog to to spread useful and practical information to help people stay safe, smart and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to speak!

Check out our services and other great resources in the links below.

Medical Waste Disposal Services 

MedWaste’s Blog Index

Medical Waste Regulations

MedWaste’s Product Store 

Home Generated Medical Waste Drop-Off Points In California


I know I can count on you all to collect everything and do it safely.

You are a great company to work with. At our pharmaceutical production laboratory. We have gallons of leftover pharmaceutical waste that are a headache for our techs to deal with. I know I can count on you all to collect everything and do it safely. I’m pleased with the personal service.


Mitchell Adam

Got questions? Need our services?

We’ll get back to you by tomorrow — latest!

Fill the form