Medications & Supplements/Prescription Drugs

Janssen Pharmaceuticals, Inc.: Ortho-Novum Birth Control Recalled for Incorrect Usage Instructions

Agency Publication Date: November 6, 2018

Summary

Janssen Pharmaceuticals is recalling 5,733 cartons of Ortho-Novum 1/35 and Ortho-Novum 7/7/7 (norethindrone/ethinyl estradiol) birth control tablets. These products were packaged with the wrong set of instructions; specifically, the Veridate dispenser contained instructions intended for a different dispenser called the Dialpak. Using the incorrect instructions could lead to confusion regarding the dosing regimen, potentially resulting in missed doses or incorrect administration of the medication. This recall affects various counts and refill options of the 28-day regimen sold nationwide.

Risk

Incorrect administration instructions for birth control can lead to user error, such as taking pills in the wrong order or missing doses entirely. This increases the risk of unintended pregnancy or hormonal fluctuations.

What You Should Do

Check your birth control packaging to see if you have Ortho-Novum 1/35 or Ortho-Novum 7/7/7 with the 'Veridate' dispenser.
For Ortho-Novum 1/35, look for lot number 18BM114 with an expiration date of 03/2020 on cartons labeled NDC 50458-176-06.
For Ortho-Novum 7/7/7, look for lot numbers 18CM120 or 18BM110 with an expiration date of 03/2020 on cartons labeled NDC 50458-178-06 or NDC 50458-178-12.
If your medication is affected, contact your healthcare provider or pharmacist immediately to ensure you are following the correct dosing schedule and to discuss alternative contraception if necessary.
Return any unused or affected medication to your pharmacy for a refund and contact Janssen Pharmaceuticals at 1-888-723-3332 for further instructions.
Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional assistance.

Your Remedy Options

Full Refund

Pharmacy refund and guidance.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen

Model:

NDC 50458-176-28

NDC 50458-176-06

Lot Numbers:

18BM114 (Exp. 03/2020)

Date Ranges: 03/2020

Product: Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day Regimen

Model:

NDC 504-58-178-28

NDC 50458-178-06

NDC 50458-178-12

Lot Numbers:

18CM120 (Exp 03/2020)

18BM110 (Exp. 03/2020)

Date Ranges: 03/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81289

Status: Resolved

Manufacturer: Janssen Pharmaceuticals, Inc.

Sold By: pharmacies; clinics

Manufactured In: United States, Puerto Rico

Units Affected: 2 products (1,777 cartons; a) 3,956 cartons; b) 1 carton)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your birth control packaging to see if you have Ortho-Novum 1/35 or Ortho-Novum 7/7/7 with the 'Veridate' dispenser.

For Ortho-Novum 1/35, look for lot number 18BM114 with an expiration date of 03/2020 on cartons labeled NDC 50458-176-06.

For Ortho-Novum 7/7/7, look for lot numbers 18CM120 or 18BM110 with an expiration date of 03/2020 on cartons labeled NDC 50458-178-06 or NDC 50458-178-12.

If your medication is affected, contact your healthcare provider or pharmacist immediately to ensure you are following the correct dosing schedule and to discuss alternative contraception if necessary.

Return any unused or affected medication to your pharmacy for a refund and contact Janssen Pharmaceuticals at 1-888-723-3332 for further instructions.

Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional assistance.

Affected Products

Product: Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen

Model:

NDC 50458-176-28

NDC 50458-176-06

Lot Numbers:

18BM114 (Exp. 03/2020)

Date Ranges: 03/2020

Product: Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day Regimen

Model:

NDC 504-58-178-28

NDC 50458-178-06

NDC 50458-178-12

Lot Numbers:

18CM120 (Exp 03/2020)

18BM110 (Exp. 03/2020)

Date Ranges: 03/2020