Acetic Acid recalls

The FDA has published 4 recalls involving Acetic Acid since 2012. The latest was reported on 19 Jun 2019. Most were for sterility. Torrent 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 recalls4since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 19 Jun 2019

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 3 75%Class III 1 25%

Why acetic acid is recalled

Companies

Torrent Pharma125%
B. Braun Medical125%
Hi-Tech Pharmacal125%
Franck's Lab Inc., d.b.a. Franck's Compounding Lab125%

By year

2019125%
2017125%
2013125%
2012125%

All acetic acid recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
19 Jun 2019Drug	CLASS II	Acetic Acid Otic Solution recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
27 Dec 2017Drug	CLASS II	0.25% Acetic Acid Irrigation USP (PIC) recalled by B. Braun MedicalAcetic Acid	B. Braun Medical	Particulate Matter	Nationwide
8 May 2013Drug	CLASS III	Acetic Acid Otic Solution recalled by Hi-Tech Pharmacal Co	Hi-Tech Pharmacal	Potency & Assay	Nationwide
22 Aug 2012Drug	CLASS II	Acetic Acid, Irrigation 3% Solution (1 Product) recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Acetic Acid?

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.