FDA Drug recall D-0053-2016
Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured…
- FDA Drug
- Class III
- terminated
- Published 2015-10-28
On 2015-10-28 the FDA classified a Class III recall of Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured… by Rx Pak, citing labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0053-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-10-13 |
| Published | 2015-10-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Rx Pak |
| Distribution | US |
Product
Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured for Concordia Pharmaceuticals, Inc., St. Michael, Barbados BB11005, Manufactured by IriSys, LLC San Diego, CA 92121, Repackaged by: RxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10
Reason
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Identifiers
| ndc | 59212-425-10 |
|---|---|
| ndc | 59212-425-11 |
| ndc | 59212-425-04 |
| code_info | Lot #: 107934 Exp 9/16, 108060 Exp 5/16 |
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-0053-2016%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.