Atropine recalls
The FDA has published 25 recalls involving Atropine since 2012. The latest was reported on 26 Aug 2026. Most were for sterility. Akorn 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 25 since 2012
Last 12 months 1 reported
Class I 3 12% of total
Ongoing 5 latest 26 Aug 2026
Recalls per month, last 24 months click a bar for that month Severity split
3 12%19 76%3 12%
Ongoing atropine recalls 5 active
All atropine recalls, newest first 25 total Reported Class Recall Company Reason Where 26 Aug 2026 Drug CLASS II Atropine Sulfate injection, USP, 1 mg/mL recalled by American Regent Atropine Sulfate American Regent Particulate Matter Nationwide 8 Jan 2025 Drug CLASS III Atropine Sulfate Ophthalmic Solution recalled by Somerset Therapeutics Atropine Sulfate Somerset Therapeutics Potency & Assay Nationwide 24 Jan 2024 Drug CLASS I Atropine Sulfate Injection, USP 1 mg/ (0.1 mg/mL) recalled by Pfizer Atropine Sulfate Pfizer Particulate Matter Nationwide 19 Jul 2023 Drug CLASS II Atropine Sulfate Injection, USP 8 mg recalled by Accord Healthcare Atropine Sulfate Accord Healthcare Particulate Matter Nationwide 7 Jun 2023 Drug CLASS II Atropine Sulfate Ophthalmic Solution recalled by Akorn Akorn Potency & Assay Nationwide 15 Feb 2023 Drug CLASS III Atropine Sulfate Ophthalmic Solution recalled by Akorn Akorn Potency & Assay Nationwide 27 Jul 2022 Drug CLASS II Atropine Sulfate Injection, USP 1.2 mg/ (0.4 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 15 Jun 2022 Drug CLASS II Isopto Atropine (atropine sulfate ophthalmic solution) recalled Isopto Atropine Mckesson Medical-Surgical Inc. Corporate Office Manufacturing (CGMP) Deviations Nationwide 2 Jun 2021 Drug CLASS II Atropine Sulfate Ophthalmic Solution recalled by Cardinal Health Cardinal Health Manufacturing (CGMP) Deviations FL, GA, SC 13 Jan 2021 Drug CLASS II Atropine Sulfate Injection, 0.8 mg/ (0.4 mg/mL) Single Dose Syringe recalled SCA Pharmaceuticals Sterility Nationwide 14 Mar 2018 Drug CLASS III Atropine Sulfate Ophthalmic 1% Solution, USP per, Sterile recalled Akorn Potency & Assay Nationwide 28 Feb 2018 Drug CLASS II Atropine Sulfate Injection in all strengths, all doses recalled Pharmedium Services Sterility Nationwide 19 Oct 2016 Drug CLASS II atropine Sulfate Injection, 0.4 mg per mL recalled Pharmedium Services Potency & Assay Nationwide 19 Oct 2016 Drug CLASS II atropine Sulfate Injection, 0.4 mg per mL recalled Pharmedium Services Potency & Assay Nationwide 19 Oct 2016 Drug CLASS II Atropine Sulfate 0.01% in 0.9% Sodium Chloride recalled Leiter's Compounding Sterility Nationwide 20 Jul 2016 Drug CLASS II Atropine Sulfate 0.4mg/mL fill in a syringe recalled Pharmakon Pharmaceuticals Sterility Nationwide 13 Jul 2016 Drug CLASS I Atropine Sulfate Injection Solution, 0.4 mg/ (0.4 mg/mL) recalled Cantrell Drug Potency & Assay Nationwide 15 Jun 2016 Drug CLASS II Atropine Sulfate 0.5% Ophthalmic Drops recalled Well Care Compounding Pharmacy Sterility NV 5 Nov 2014 Drug CLASS II Atropine sulfate 1 mg/mL injectable recalled by Martin Avenue Pharmacy Martin Avenue Pharmacy Sterility Nationwide 5 Nov 2014 Drug CLASS II Atropine sulfate 2 mg/mL injectable recalled by Martin Avenue Pharmacy Martin Avenue Pharmacy Sterility Nationwide 3 Sep 2014 Drug CLASS I Atropine Sulfate 0.4 mg/ml Injection recalled Pharmakon Pharmaceuticals Labeling Errors 4 states 29 Jan 2014 Drug CLASS II Atropine Sulfate/Diphenoxylate HCL, Tablet, 0.025 mg/2.5 mg recalled Aidapak Services Labeling Errors 4 states 21 Aug 2013 Drug CLASS II Atropine Injection, compounded by Pallimed Solutions recalled Pallimed Solutions Sterility Nationwide 17 Jul 2013 Drug CLASS II Atropine Sulfate 50 mg/ml Injection recalled by Lowlite Investments Lowlite Investments Sterility Nationwide 22 Aug 2012 Drug CLASS II Atropine Sulfate 0.4mg/ML Injectable recalled Franck's Lab Inc., d.b.a. Franck's Compounding Lab Sterility Nationwide
Should you stop taking Atropine?
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.