Acetylcysteine recalls
The FDA has published 17 recalls involving Acetylcysteine since 2012. The latest was reported on 26 Aug 2026. Most were for sterility. Clinical Specialties Compounding Pharmacy 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 recalls 17 since 2012
Last 12 months 2 reported
Class I 1 6% of total
Ongoing 2 latest 26 Aug 2026
Recalls per month, last 24 months click a bar for that month Severity split
1 6%16 94%0 0%
Why acetylcysteine is recalled
Ongoing acetylcysteine recalls 2 active
All acetylcysteine recalls, newest first 17 total Reported Class Recall Company Reason Where 26 Aug 2026 Drug CLASS II Acetylcysteine Solution, USP, 10% (100 mg/mL) recalled Acetylcysteine American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Acetylcysteine Solution, USP, 20% (200 mg/mL) recalled Acetylcysteine American Regent Particulate Matter Nationwide 1 Feb 2023 Drug CLASS II Acetylcysteine 10% Ophthalmic Solution recalled by Pharmacy Innovations Pharmacy Innovations Sterility Nationwide 20 Feb 2019 Drug CLASS II Acetylcysteine Ophthalmic Solution, 100mg/ml recalled Promise Pharmacy Sterility Nationwide 7 Nov 2018 Drug CLASS II Acetylcysteine Injection 10 mg/ (2 mg/mL) recalled by Pharm D Solutions Pharm D Solutions Sterility Nationwide 18 Jul 2018 Drug CLASS II Acetylcysteine for Injection (200 mg/mL) recalled by Akorn Akorn Manufacturing (CGMP) Deviations Nationwide 23 Sep 2015 Drug CLASS II Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial recalled The Compounding Pharmacy of America Sterility Nationwide 28 May 2014 Drug CLASS I Acetylcysteine Solution, USP, 10% vial recalled Ben Venue Laboratories Particulate Matter Nationwide 12 Mar 2014 Drug CLASS II Acetylcysteine 10% ophthalmic recalled by Natures Pharmacy & Natures Pharmacy & Compounding Center Sterility NC 25 Sep 2013 Drug CLASS II Acetylcysteine 20% Solution recalled by JCB Labs JCB Labs Sterility Nationwide 18 Sep 2013 Drug CLASS II Acetylcysteine 100 MG/ML Inj Soln, all presentations recalled Beacon Hill Medical Pharmacy, P.C Sterility Nationwide 21 Aug 2013 Drug CLASS II Acetylcysteine Ophthalmic Solution recalled by Pallimed Solutions Pallimed Solutions Sterility Nationwide 10 Jul 2013 Drug CLASS II Acetylcysteine 20 % solution recalled by Clinical Specialties Clinical Specialties Compounding Pharmacy Sterility FL, GA, SC 10 Jul 2013 Drug CLASS II Acetylcysteine 10 % Solution recalled by Clinical Specialties Clinical Specialties Compounding Pharmacy Sterility FL, GA, SC 10 Jul 2013 Drug CLASS II Acetylcysteine 2 % Solution recalled by Clinical Specialties Clinical Specialties Compounding Pharmacy Sterility FL, GA, SC 22 May 2013 Drug CLASS II Acetylcysteine Injection, all strengths recalled by FVS Holdings FVS Holdings Sterility Nationwide 22 Aug 2012 Drug CLASS II Acetylcysteine, Ophthalmic In Artificial Tears 10% Solution recalled Franck's Lab Inc., d.b.a. Franck's Compounding Lab 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.