Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16 — Class II drug recall D-0785-2016
Terminated recall by Safecor Health, LLC, reported 2016-04-06, distributed in NY. Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
| Recall number | D-0785-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Safecor Health, LLC, Woburn, MA, United States |
| Recall initiated | 2015-07-16 |
| Classified | 2016-03-29 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2016-03-30 |
| Distributed | NY |
| Quantity | 23 cups |
| Reason classes | labeling, potency |
| Lot numbers | 06/16, 914227 |
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 for recall
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
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-0785-2016. 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.