Haloperidol Oral Solution — Class II drug recall D-0661-2016
Terminated recall by Safecor Health, LLC, reported 2016-02-17, distributed in NJ. Defective Container: Confirmed customer complaints of leaking bottles.
| Recall number | D-0661-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Safecor Health, LLC, Woburn, MA, United States |
| Recall initiated | 2015-03-02 |
| Classified | 2016-02-11 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2016-02-25 |
| Distributed | NJ |
| Quantity | 3,532 amber |
| Reason classes | packaging |
| NDC | 54838-0501-40 |
| Lot numbers | 01/16, 846881 |
Product
Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.
Reason for recall
Defective Container: Confirmed customer complaints of leaking bottles.
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-0661-2016. 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.