CLASS III Drug recall · Reported 1 Oct 2014 · FDA Enforcement Report
Olanzapine Orally Disintegrating Tablets 5 mg recalled by Apotex
Apotex is recalling Olanzapine Orally Disintegrating Tablets 5 mg, distributed nationwide in the US. The recall was initiated on 18 Apr 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-1609-2014
- FDA event ID
- 69177
- Recalling firm
- Apotex, Weston, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Apr 2014
- FDA classified
- 24 Sep 2014
- Reported
- 1 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 18 Apr 2014 | Recall initiated by company | |
| 24 Sep 2014 | Classified by FDA | +159 days |
| 1 Oct 2014 | Published in enforcement report | +7 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: Out of specification (OOS) results at the 9 month temperature 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
Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Which lots are affected?
Lot # KM4951; Exp. 04/15
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 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 |
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| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
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Other Olanzapine Orally Disintegrating recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Olanzapine Orally Disintegrating Tablets recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Olanzapine Orally Disintegrating Tablets, 5 mg ( unit dose) recalled | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |