CLASS II Drug recall · Reported 20 May 2015 · FDA Enforcement Report
Ortho-Cept (0.15 mg desogestrel recalled by Janssen Pharmaceuticals
Janssen Pharmaceuticals is recalling Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets blister ( and)/ 6, distributed nationwide in the US. The recall was initiated on 29 Apr 2015 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-1063-2015
- FDA event ID
- 71064
- Recalling firm
- Janssen Pharmaceuticals, Titusville, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Apr 2015
- FDA classified
- 11 May 2015
- Reported
- 20 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 29 Apr 2015 | Recall initiated by company | |
| 11 May 2015 | Classified by FDA | +12 days |
| 20 May 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Canada
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot # 13CM724, Exp.09/15 (US) Lot # (L) 13DM732, Exp. 09/15 (Canada)
Where was it sold?
Nationwide and Canada
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.
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-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets recalled | Janssen Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Risperdal Consta (risperiDONE), 25 mg Dose Pack recalledRisperdal Consta | Janssen Pharmaceuticals | Sterility | Nationwide |