Guaifenesin recalls

The FDA has published 5 recalls involving Guaifenesin since 2014. The latest was reported on 12 Feb 2025. Most were for potency & assay. Traxx International 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 recalls5since 2014

Last 12 months0reported

Class I00% of total

Ongoing1latest 12 Feb 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 1 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 3 60%Class III 2 40%

Why guaifenesin is recalled

Companies

Brands

By year

2025120%
2023120%
2021120%
2015120%
2014120%

Ongoing guaifenesin recalls

1 active

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Guaifenesin Oral Solution, 300 mg/, Sugar Free/Alcohol Free recalled	Akorn	Potency & Assay	Nationwide

All guaifenesin recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
12 Feb 2025Drug	CLASS III	Guaifenesin and Codeine Phosphate Oral Solution recalled by PAI HoldingsGuaifenesin And Codeine Phosphate	PAI Holdings	Potency & Assay	OH
7 Jun 2023Drug	CLASS II	Guaifenesin Oral Solution, 300 mg/, Sugar Free/Alcohol Free recalled	Akorn	Potency & Assay	Nationwide
29 Dec 2021Drug	CLASS II	Rompe Pecho Ex Expectorant recalled by Efficient LaboratoriesRompe Pecho	Efficient Laboratories	Sterility	Nationwide
29 Apr 2015Drug	CLASS III	Mucinex DM (guaifenesin 600mg recalled by Reckitt BenckiserMucinex Dm	Reckitt Benckiser	Packaging Defects	Nationwide
26 Mar 2014Drug	CLASS II	Guaifenesin USP Drums, CAS No. 93-14-1, Reg recalled	Traxx International	Foreign Material	Nationwide

Should you stop taking Guaifenesin?

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.