Procaine recalls

The FDA has published 7 recalls involving Procaine since 2012. The latest was reported on 20 Jul 2022. Most were for sterility. FVS Holdings 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 recalls7since 2012

Last 12 months0reported

Class I00% of total

Ongoing1latest 20 Jul 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 0 0%Class II 7 100%Class III 0 0%

Why procaine is recalled

Sterility7100%

Companies

FVS Holdings114%
Franck's Lab Inc., d.b.a. Franck's Compounding Lab114%
TMC Acquisition114%
RXQ Compounding114%
Promise Pharmacy114%
Western Drug114%
The Compounding Shop114%

By year

2022114%
2019229%
2015114%
2013229%
2012114%

Ongoing procaine recalls

1 active

Reported	Class	Recall	Company	Reason	Where
20 Jul 2022Drug	CLASS II	Procaine HCL 2% (20mg/mL)-vial, Refrigerate, Tailor Made Compounding recalled	TMC Acquisition	Sterility	Nationwide

All procaine recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
20 Jul 2022Drug	CLASS II	Procaine HCL 2% (20mg/mL)-vial, Refrigerate, Tailor Made Compounding recalled	TMC Acquisition	Sterility	Nationwide
14 Aug 2019Drug	CLASS II	Procaine HCL 20 MG/ML (Mdv) Injectable Solution per vial recalled	RXQ Compounding	Sterility	Nationwide
20 Feb 2019Drug	CLASS II	Procaine HCl, 2% injection vial recalled by Promise Pharmacy	Promise Pharmacy	Sterility	Nationwide
9 Dec 2015Drug	CLASS II	Procaine HCl Injection 1%, 2%, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
12 Jun 2013Drug	CLASS II	Procaine 1% Injectable and vials recalled by The Compounding Shop	The Compounding Shop	Sterility	4 states
22 May 2013Drug	CLASS II	Procaine Hydrochloride Injection, all strengths recalled by FVS Holdings	FVS Holdings	Sterility	Nationwide
22 Aug 2012Drug	CLASS II	Procaine HCL, P.f. 1% Injectable recalled by Franck's Lab Inc., d.b.a.	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Procaine?

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.