CLASS III Drug recall · Reported 28 Oct 2015 · FDA Enforcement Report
Donnatal (Phenobarbital, Hyoscyamine Sulfate recalled by Rx PAK
Rx PAK is recalling Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), distributed nationwide in the US. The recall was initiated on 13 Oct 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0053-2016
- FDA event ID
- 72457
- Recalling firm
- Rx PAK, Memphis, TN
- Brand
- Donnatal
- Manufacturer
- Advanz Pharma (US) Corp.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Oct 2015
- FDA classified
- 21 Oct 2015
- Reported
- 28 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
Timeline
| 13 Oct 2015 | Recall initiated by company | |
| 21 Oct 2015 | Classified by FDA | +8 days |
| 28 Oct 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Which lots are affected?
Lot #: 107934 Exp 9/16, 108060 Exp 5/16
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Phenobarbital recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Phenobarbital Elixir, USP 20 mg/, 1 Pint recalled by Monarch PCM | Monarch PCM | Other | TN |
| Drug | CLASS II | Phenobarbital Sodium Injection, USP, 130 mg/mL recalledPhenobarbital Sodium | Vitae Enim Vitae Scientific | Sterility | Nationwide |
| Drug | CLASS II | Phenobarbital Sodium Injection, USP, 65mg/mL recalledPhenobarbital Sodium | Vitae Enim Vitae Scientific | Sterility | Nationwide |
| Drug | CLASS II | Phenobarbital Tablets, USP 32.4 mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Phenobarbital Oral Solution, USP, 20 mg recalled by Torrent Pharma | Torrent Pharma | Sterility | Nationwide |