FDA Drug recall D-0785-2016
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG:…
- FDA Drug
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II recall of Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG:… by Safecor Health, citing labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0785-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-16 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Safecor Health |
| Distribution | NY |
Product
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.
Reason
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Identifiers
| code_info | Lot #: 914227; Exp 06/16 |
|---|
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-0785-2016%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.