Phenobarbital recalls

The FDA has published 11 recalls involving Phenobarbital since 2016. The latest was reported on 13 Apr 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 recalls11since 2016

Last 12 months0reported

Class I218% of total

Ongoing0latest 13 Apr 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 18%Class II 9 82%Class III 0 0%

Why phenobarbital is recalled

Companies

Brands

Phenobarbital Sodium218%
Phenobarbital19%

By year

2022218%
202119%
2019218%
2017545%
201619%

All phenobarbital recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
13 Apr 2022Drug	CLASS II	Phenobarbital Sodium Injection, USP, 130 mg/mL recalledPhenobarbital Sodium	Vitae Enim Vitae Scientific	Sterility	Nationwide
13 Apr 2022Drug	CLASS II	Phenobarbital Sodium Injection, USP, 65mg/mL recalledPhenobarbital Sodium	Vitae Enim Vitae Scientific	Sterility	Nationwide
2 Jun 2021Drug	CLASS II	Phenobarbital Tablets, USP 4 mg recalled by Cardinal Health	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
19 Jun 2019Drug	CLASS II	Phenobarbital Oral Solution, USP, 20 mg recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
17 Apr 2019Drug	CLASS II	Phenobarbital Oral Solution, USP 20 mg/, unit dose cup recalled by Lohxa	Lohxa	Other	MA, NY, WY
30 Aug 2017Drug	CLASS II	Phenobarbital Tablets USP, 100 mg, a) bottles recalled by C. O. Truxton	C. O. Truxton	Labeling Errors	Nationwide
30 Aug 2017Drug	CLASS II	Phenobarbital Tablets USP, 60 mg recalled by C. O. Truxton	C. O. Truxton	Labeling Errors	Nationwide
30 Aug 2017Drug	CLASS II	Phenobarbital Tablets USP, 15 mg recalled by C. O. Truxton	C. O. Truxton	Labeling Errors	Nationwide
30 Aug 2017Drug	CLASS I	Phenobarbital Tablets USP, 15 mg recalled by C. O. Truxton	C. O. Truxton	Other	Nationwide
30 Aug 2017Drug	CLASS I	Phenobarbital Tablets USP, 30 mg recalled by C. O. Truxton	C. O. Truxton	Labeling Errors	Nationwide

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.