Olanzapine Orally Disintegrating Tablets 5 mg — Class III drug recall D-1609-2014
Terminated recall by Apotex Corp., reported 2014-10-01, distributed nationwide. Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
| Recall number | D-1609-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2014-04-18 |
| Classified | 2014-09-24 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2017-04-07 |
| Distributed | Nationwide (US) |
| Quantity | 5,397 bottles |
| Reason classes | potency, specification failure |
| NDC | 60505-3275-03 |
| Lot numbers | 04/15, KM4951 |
Product
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
Reason for recall
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1609-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.