Midazolam HCl 1 mg/ml in 0 — Class I drug recall D-1566-2014
Terminated recall by Pharmakon Pharmaceuticals, reported 2014-09-03, distributed in IL, IN, MD, TX. Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
| Recall number | D-1566-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmakon Pharmaceuticals, Noblesville, IN, United States |
| Recall initiated | 2014-04-21 |
| Classified | 2014-08-26 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2014-12-03 |
| Distributed | IL, IN, MD, TX |
| Reason classes | undeclared allergen |
| NDC | 45183-0796-48, 45183-0989-41 |
| Lot numbers | E21294DK1C, E21294DK3C |
| Expiration dates | 2014-05-22, 2014-06-08 |
Product
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.
Reason for recall
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
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-1566-2014. 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.