Acetylcysteine recalls

The FDA has published 6 recalls involving Acetylcysteine since 2013. The latest was reported on 26 Aug 2026. Most were for particulate matter. American Regent 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 recalls6since 2013

Last 12 months2reported

Class I117% of total

Ongoing2latest 26 Aug 2026

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 2 0

Severity split

Class I 1 17%Class II 5 83%Class III 0 0%

Why acetylcysteine is recalled

Companies

By year

2026233%
2018233%
2014117%
2013117%

Ongoing acetylcysteine recalls

2 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Acetylcysteine Solution, USP, 10% (100 mg/mL) recalledAcetylcysteine	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Acetylcysteine Solution, USP, 20% (200 mg/mL) recalledAcetylcysteine	American Regent	Particulate Matter	Nationwide

All acetylcysteine recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Acetylcysteine Solution, USP, 10% (100 mg/mL) recalledAcetylcysteine	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Acetylcysteine Solution, USP, 20% (200 mg/mL) recalledAcetylcysteine	American Regent	Particulate Matter	Nationwide
7 Nov 2018Drug	CLASS II	Acetylcysteine Injection 10 mg/ (2 mg/mL) recalled by Pharm D Solutions	Pharm D Solutions	Sterility	Nationwide
18 Jul 2018Drug	CLASS II	Acetylcysteine for Injection (200 mg/mL) recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide
28 May 2014Drug	CLASS I	Acetylcysteine Solution, USP, 10% vial recalled	Ben Venue Laboratories	Particulate Matter	Nationwide
22 May 2013Drug	CLASS II	Acetylcysteine Injection, all strengths recalled by FVS Holdings	FVS Holdings	Sterility	Nationwide

Should you stop taking Acetylcysteine?

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.