FDA Drug recall D-0661-2016
Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc
- FDA Drug
- Class II
- terminated
- Published 2016-02-17
On 2016-02-17 the FDA classified a Class II recall of Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc by Safecor Health, citing defective Container: Confirmed customer complaints of leaking bottles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0661-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-02 |
| Published | 2016-02-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Safecor Health |
| Distribution | NJ |
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
Defective Container: Confirmed customer complaints of leaking bottles.
Identifiers
| code_info | Lot #846881; Exp 01/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0661-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.