FDA Drug recall D-1063-2015
Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blis…
- FDA Drug
- Class II
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class II recall of Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blis… by Janssen Pharmaceuticals, citing subpotent Drug.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1063-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-29 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Janssen Pharmaceuticals |
| Distribution | US |
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
Subpotent Drug
Identifiers
| code_info | Lot # 13CM724, Exp.09/15 (US) Lot # (L) 13DM732, Exp. 09/15 (Canada) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1063-2015%22
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