Phenol recalls

The FDA has published 8 recalls involving Phenol since 2014. The latest was reported on 2 Feb 2022. Most were for sterility. Edge Pharma 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 recalls8since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 2 Feb 2022

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 8 100%Class III 0 0%

Why phenol is recalled

Companies

Edge Pharma225%
Pharm D Solutions225%
Assurance Infusion113%
Martin Avenue Pharmacy113%
Aidapak Services113%
Specialty Medicine Compounding Pharmacy113%

By year

2022225%
2020113%
2018225%
2014338%

All phenol recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
2 Feb 2022Drug	CLASS II	Phenol, Sterile Solution for Injection (PF), 6% per vial recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022Drug	CLASS II	Phenol, Topical Solution (PF) Multiple Dose Vial recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
22 Jan 2020Drug	CLASS II	Phenol 2.5% Sterile Solution in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
7 Nov 2018Drug	CLASS II	Phenol 7% and Glycerin Aqueous Solution Injectable recalled	Pharm D Solutions	Sterility	Nationwide
7 Nov 2018Drug	CLASS II	Phenol 5% and Glycerin Aqueous Solution Injection recalled	Pharm D Solutions	Sterility	Nationwide
5 Nov 2014Drug	CLASS II	Phenol 10% injectable recalled by Martin Avenue Pharmacy	Martin Avenue Pharmacy	Sterility	Nationwide
29 Jan 2014Drug	CLASS II	Phenol, Lozenge, 29 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Phenol, 6%, Injectable recalled by Specialty Medicine	Specialty Medicine Compounding Pharmacy	Sterility	MI

Should you stop taking Phenol?

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.