Ortho-Cept — Class II drug recall D-1063-2015
Terminated recall by Janssen Pharmaceuticals, Inc., reported 2015-05-20, distributed nationwide. Subpotent Drug
| Recall number | D-1063-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Janssen Pharmaceuticals, Inc., Titusville, NJ, United States |
| Recall initiated | 2015-04-29 |
| Classified | 2015-05-11 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2018-07-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | potency |
| NDC | 50458-0196-15 |
| Lot numbers | 09/15, 13CM724, 13DM732 |
Product
Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15.
Reason for recall
Subpotent Drug
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-1063-2015. 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.