Ortho-Novum 1/35 — Class II drug recall D-0217-2019
Terminated recall by Janssen Pharmaceuticals, Inc., reported 2018-11-14, distributed nationwide. Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instruct
| Recall number | D-0217-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Janssen Pharmaceuticals, Inc., Titusville, NJ, United States |
| Recall initiated | 2018-10-23 |
| Classified | 2018-11-06 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2019-10-30 |
| Distributed | Nationwide (US) |
| Quantity | 1,777 cartons |
| Reason classes | labeling |
| NDC | 50458-0176-06, 50458-0176-28 |
| Lot numbers | 18BM114 |
| Expiration dates | 2020-03 |
Product
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.
Reason for recall
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0217-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.