Janssen Ortho-Novum 1/35 Tablets: Incorrect Dispenser Instructions
Janssen recalls Ortho-Novum 1/35 birth control tablets due to incorrect dispenser instructions that could lead to improper use. Affected units include specific NDC numbers and lots.
Lower-risk recall
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Contact the company
What happened, in plain English
Janssen is recalling Ortho-Novum 1/35 birth control tablets because the instructions included for the Veridate dispenser were written for a different dispenser type. This could lead to incorrect use if someone follows the wrong instructions. Read more at govinfonow.com/recall/39476-janssen-ortho-novum-1-35-tablets-incorrect-dispenser-instructions.
Source Summary by GovInfoNow · govinfonow.com/recall/39476-janssen-ortho-novum-1-35-tablets-incorrect-dispenser-instructions · Updated October 5, 2026 · FDA enforcement record: FDA #D-0217-2019
Cite this page
“Janssen Ortho-Novum 1/35 Tablets: Incorrect Dispenser Instructions.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39476-janssen-ortho-novum-1-35-tablets-incorrect-dispenser-instructions. Based on FDA recall #D-0217-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0217-2019%22&limit=1).
Why it’s dangerous
The product comes with instructions meant for the Dialpak dispenser but is labeled for the Veridate dispenser. This mismatch could cause users to follow incorrect usage steps, potentially leading to improper hormone intake.
Who’s affected
Women who have been prescribed Ortho-Novum 1/35 birth control tablets with the specific NDC 50458-176-28 and lot #18BM114 are affected. Those using the product without proper understanding of the dispenser instructions are at slightly higher risk.
How to tell if you have this one
Check for the NDC code 50458-176-28 on the product packaging. The lot number 18BM114 is also associated with this recall. The product is prescription-only and sold in specific packaging with 6 Veridate dispensers and refills.
- Brand
Janssen- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0217-2019 | Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560.; Lot # 18BM114, Exp. 03/2020 | 1,777 cartons |
| D-0218-2019 | 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 per pouch, packaged in a) 6 Veridate Tablet Dispensers and 6 Refill pouches (NDC 504-58-178-28) per carton (NDC 50458-178-06); and b) 12 Veridate Tablet Dispenser Refills (NDC 50458-178-12) per carton (NDC 50458-178-12), Clinic Package, , Rx Only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560.; Lot #: a) 18CM120, Exp 03/2020; b) 18BM110, Exp. 03/2020 | a) 3,956 cartons; b) 1 carton |
What to do — step by step
Check Product Details
Look for the NDC code 50458-176-28 and lot number 18BM114 on the packaging to confirm if the product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The product is safe to use if the instructions are followed correctly. However, the recall is due to incorrect labeling that could lead to improper use.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0217-2019 (October 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0217-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.