Phenobarbital recalls
The FDA has published 18 recalls involving Phenobarbital since 2014. The latest was reported on 25 May 2022. Most were for labeling errors. C. O. Truxton has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 18 since 2014
Last 12 months 0 reported
Class I 2 11% of total
Ongoing 0 latest 25 May 2022
Recalls per month, last 24 months click a bar for that month Severity split
2 11%14 78%2 11%
Why phenobarbital is recalled
All phenobarbital recalls, newest first 18 total Reported Class Recall Company Reason Where 25 May 2022 Drug CLASS III Phenobarbital Elixir, USP 20 mg/, 1 Pint recalled by Monarch PCM Monarch PCM Other TN 13 Apr 2022 Drug CLASS II Phenobarbital Sodium Injection, USP, 130 mg/mL recalled Phenobarbital Sodium Vitae Enim Vitae Scientific Sterility Nationwide 13 Apr 2022 Drug CLASS II Phenobarbital Sodium Injection, USP, 65mg/mL recalled Phenobarbital Sodium Vitae Enim Vitae Scientific Sterility Nationwide 2 Jun 2021 Drug CLASS II Phenobarbital Tablets, USP 32.4 mg recalled by Cardinal Health Cardinal Health Manufacturing (CGMP) Deviations FL, GA, SC 19 Jun 2019 Drug CLASS II Phenobarbital Oral Solution, USP, 20 mg recalled by Torrent Pharma Torrent Pharma Sterility Nationwide 17 Apr 2019 Drug CLASS II Phenobarbital Oral Solution, USP 20 mg/, unit dose cup recalled by Lohxa Lohxa Other MA, NY, WY 30 Aug 2017 Drug CLASS II Phenobarbital Tablets USP, 100 mg, a) bottles recalled by C. O. Truxton C. O. Truxton Labeling Errors Nationwide 30 Aug 2017 Drug CLASS II Phenobarbital Tablets USP, 60 mg recalled by C. O. Truxton C. O. Truxton Labeling Errors Nationwide 30 Aug 2017 Drug CLASS II Phenobarbital Tablets USP, 15 mg recalled by C. O. Truxton C. O. Truxton Labeling Errors Nationwide 30 Aug 2017 Drug CLASS I Phenobarbital Tablets USP, 15 mg recalled by C. O. Truxton C. O. Truxton Other Nationwide 30 Aug 2017 Drug CLASS I Phenobarbital Tablets USP, 30 mg recalled by C. O. Truxton C. O. Truxton Labeling Errors Nationwide 30 Nov 2016 Drug CLASS II Phenobarbital Tablets, USP 60mg 100=count recalled Phenobarbital West-Ward Pharmaceuticals Potency & Assay Nationwide 6 Apr 2016 Drug CLASS II Phenobarbital/Hyoscyamine/ Atropine/Scopolamine recalled Safecor Health Other NY 28 Oct 2015 Drug CLASS III Donnatal (Phenobarbital, Hyoscyamine Sulfate recalled by Rx PAK Donnatal Rx PAK Packaging Defects Nationwide 29 Jan 2014 Drug CLASS II PHENobarbital, Tablet, 97.2 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 29 Jan 2014 Drug CLASS II PHENobarbital, Tablet, 97.2 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 29 Jan 2014 Drug CLASS II PHENobarbital, Tablet, 64.8 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 22 Jan 2014 Drug CLASS II PHENobarbital/ Hyoscyamine/ Atropine/ Scopolamine, Tablet recalled Aidapak Services Labeling Errors 4 states
Should you stop taking Phenobarbital?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.