Epinephrine — Class II drug recall D-0589-2016
Terminated recall by Pharmakon Pharmaceuticals, reported 2016-02-03, distributed nationwide. Subpotent drug.
| Recall number | D-0589-2016 |
|---|---|
| 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 | 1,150 |
| Reason classes | potency |
Product
Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Reason for recall
Subpotent drug.
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-0589-2016. 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.