Donnatal — Class III drug recall D-0053-2016
Terminated recall by Rx PAK, reported 2015-10-28, distributed nationwide. Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingr
| Recall number | D-0053-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rx PAK, Memphis, TN, United States |
| Recall initiated | 2015-10-13 |
| Classified | 2015-10-21 |
| Reported by FDA | 2015-10-28 |
| Terminated | 2016-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 2,530 bottles |
| Reason classes | labeling |
| NDC | 59212-0425, 59212-0425-04, 59212-0425-10, 59212-0425-11 |
| Lot numbers | 107934, 108060, 5/16, 9/16 |
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 for recall
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
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-0053-2016. 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.