Loxapine Capsules USP — Class III drug recall D-1399-2012
Terminated recall by Watson Laboratories Inc, reported 2012-07-11, distributed nationwide. Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged
| Recall number | D-1399-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Watson Laboratories Inc, Corona, CA, United States |
| Recall initiated | 2012-04-17 |
| Classified | 2012-06-29 |
| Reported by FDA | 2012-07-11 |
| Terminated | 2013-03-18 |
| Distributed | Nationwide (US) |
| Quantity | 8,254 bottles |
| Reason classes | labeling |
| NDC | 00591-0369-01 |
| Lot numbers | 108094A |
Product
Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.
Reason for recall
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
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-1399-2012. 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.