Midazolam HCl Syrup — Class II drug recall D-0657-2016
Terminated recall by Safecor Health, LLC, reported 2016-02-17, distributed in NY. Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard
| Recall number | D-0657-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Safecor Health, LLC, Woburn, MA, United States |
| Recall initiated | 2015-08-13 |
| Classified | 2016-02-10 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2016-02-25 |
| Distributed | NY |
| Quantity | 132 units |
| Lot numbers | 932333 |
| Expiration dates | 2016-08-04 |
Product
Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605.
Reason for recall
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
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-0657-2016. 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.