CLASS II Drug recall · Reported 14 Nov 2018 · FDA Enforcement Report
Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets recalled
Janssen Pharmaceuticals is recalling Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen, distributed nationwide in the US. The recall was initiated on 23 Oct 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0217-2019
- FDA event ID
- 81289
- Recalling firm
- Janssen Pharmaceuticals, Titusville, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Oct 2018
- FDA classified
- 6 Nov 2018
- Reported
- 14 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Hormones & Birth Control
Timeline
| 23 Oct 2018 | Recall initiated by company | |
| 6 Nov 2018 | Classified by FDA | +14 days |
| 14 Nov 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Which lots are affected?
Lot # 18BM114, Exp. 03/2020
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 81289| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets recalled | Janssen Pharmaceuticals | Packaging Defects | Nationwide |
More recalls from Janssen Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets recalled | Janssen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Ortho-Cept (0.15 mg desogestrel recalled by Janssen Pharmaceuticals | Janssen Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Risperdal Consta (risperiDONE), 25 mg Dose Pack recalledRisperdal Consta | Janssen Pharmaceuticals | Sterility | Nationwide |