CLASS III Drug recall · Reported 7 May 2014 · FDA Enforcement Report
Risperidone Oral Solution, 1 mg/mL recalled by Apotex
Apotex is recalling Risperidone Oral Solution, 1 mg/mL, distributed nationwide in the US. The recall was initiated on 20 Mar 2014 and the FDA has classified it as Class III.
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-1299-2014
- FDA event ID
- 67985
- Recalling firm
- Apotex, Toronto
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Mar 2014
- FDA classified
- 1 May 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 20 Mar 2014 | Recall initiated by company | |
| 1 May 2014 | Classified by FDA | +42 days |
| 7 May 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
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
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Which lots are affected?
Lot #: KD4855, Exp 06/14
Where was it sold?
Nationwide and Puerto Rico.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Apotex
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | 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 II | Risperdal Consta (risperiDONE), 25 mg Dose Pack recalledRisperdal Consta | Janssen Pharmaceuticals | Sterility | Nationwide |