Midazolam — Class II drug recall D-0595-2016
Terminated recall by Pharmakon Pharmaceuticals, reported 2016-02-03, distributed nationwide. Stability data does not support expiry.
| Recall number | D-0595-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmakon Pharmaceuticals, Noblesville, IN, United States |
| Recall initiated | 2015-08-19 |
| Classified | 2016-01-27 |
| Reported by FDA | 2016-02-03 |
| Terminated | 2017-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 665 |
| Reason classes | specification failure |
Product
Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Reason for recall
Stability data does not support expiry.
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-0595-2016. 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.