CLASS II Drug recall · Reported 13 Aug 2014 · FDA Enforcement Report
Risperdal Consta (risperiDONE), 25 mg Dose Pack recalled
Janssen Pharmaceuticals is recalling Risperdal Consta (risperiDONE), 25 mg Dose Pack, distributed nationwide in the US. The recall was initiated on 11 Sep 2013 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-1514-2014
- FDA event ID
- 66261
- Recalling firm
- Janssen Pharmaceuticals, Titusville, NJ
- Brand
- Risperdal Consta
- Manufacturer
- Janssen Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Sep 2013
- FDA classified
- 5 Aug 2014
- Reported
- 13 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
Timeline
| 11 Sep 2013 | Recall initiated by company | |
| 5 Aug 2014 | Classified by FDA | +328 days |
| 13 Aug 2014 | 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
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Which lots are affected?
Vial - 4212AAP1, Kit - 309316, Exp. 07/15
Where was it sold?
Nationwide
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 | Ortho-Cept (0.15 mg desogestrel recalled by Janssen Pharmaceuticals | Janssen Pharmaceuticals | Potency & Assay | Nationwide |
Other Risperidone recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Risperidone 1mg/ML recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | RisperiDONE Oral Solution, USP, 1 mg/mL recalled by Torrent Pharma | Torrent Pharma | Sterility | Nationwide |
| Drug | CLASS II | RisperiDONE Oral Solution, USP, 1 mg/mL recalled by Torrent Pharma | Torrent Pharma | Sterility | Nationwide |
| Drug | CLASS III | Risperidone Oral Solution, 1 mg/mL recalled by Apotex | Apotex | Potency & Assay | Nationwide |