CLASS I Drug recall · Reported 30 Aug 2017 · FDA Enforcement Report
Phenobarbital Tablets USP, 15 mg recalled by C. O. Truxton
C. O. Truxton is recalling Phenobarbital Tablets USP, 15 mg, distributed nationwide in the US. The recall was initiated on 20 Apr 2017 and the FDA has classified it as Class I.
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-1111-2017
- FDA event ID
- 77082
- Recalling firm
- C. O. Truxton, Bellmawr, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 Apr 2017
- FDA classified
- 22 Aug 2017
- Reported
- 30 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Other Reasons
Timeline
| 20 Apr 2017 | Recall initiated by company | |
| 22 Aug 2017 | Classified by FDA | +124 days |
| 30 Aug 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Product as listed by the FDA
Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Which lots are affected?
Lot # 70952A; Exp. 11/17
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 products in this recall event
5 other products · FDA event 77082This product is part of a recall event; the main page for the event is Phenobarbital Tablets USP, 30 mg recalled by C. O. Truxton.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Phenobarbital Tablets USP, 30 mg recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide | |
| CLASS II | Phenobarbital Tablets USP, 15 mg recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide | |
| CLASS II | Amitriptyline HCL Tablets, USP 50 mg recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide | |
| CLASS II | Phenobarbital Tablets USP, 60 mg recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide | |
| CLASS II | Phenobarbital Tablets USP, 100 mg, a) bottles recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide |
More recalls from C. O. Truxton
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenobarbital Tablets USP, 100 mg, a) bottles recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide |
| Drug | CLASS II | Phenobarbital Tablets USP, 60 mg recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide |
| Drug | CLASS II | Amitriptyline HCL Tablets, USP 50 mg recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide |
| Drug | CLASS II | Phenobarbital Tablets USP, 15 mg recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide |
| Drug | CLASS I | Phenobarbital Tablets USP, 30 mg recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide |
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 |