CLASS II Drug recall · Reported 14 Nov 2018 · FDA Enforcement Report
Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets recalled
Janssen Pharmaceuticals is recalling Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75, 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-0218-2019
- 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
- Packaging Defects
- 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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
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 #: a) 18CM120, Exp 03/2020; b) 18BM110, 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 81289This product is part of a recall event; the main page for the event is Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets recalled | Janssen Pharmaceuticals | Other | Nationwide |
More recalls from Janssen Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets recalled | Janssen Pharmaceuticals | Other | 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 |