Atropine recalls

The FDA has published 11 recalls involving Atropine since 2013. The latest was reported on 26 Aug 2026. Most were for sterility. Pharmedium Services 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 recalls11since 2013

Last 12 months1reported

Class I218% 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 1 0

Severity split

Class I 2 18%Class II 9 82%Class III 0 0%

Why atropine is recalled

Companies

Pharmedium Services327%
Pallimed Solutions19%
Cantrell Drug19%
SCA Pharmaceuticals19%
Mckesson Medical-Surgical Inc. Corporate Office19%
Nephron Sterile Compounding Center19%
Accord Healthcare19%
Pfizer19%

Brands

Atropine Sulfate327%
Isopto Atropine19%

By year

202619%
202419%
202319%
2022218%
202119%
201819%
2016327%
201319%

Ongoing atropine recalls

2 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Atropine Sulfate injection, USP, 1 mg/mL recalled by American RegentAtropine Sulfate	American Regent	Particulate Matter	Nationwide
24 Jan 2024Drug	CLASS I	Atropine Sulfate Injection, USP 1 mg/ 1 mg/mL), Lifeshield recalledAtropine Sulfate	Pfizer	Particulate Matter	Nationwide

All atropine recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Atropine Sulfate injection, USP, 1 mg/mL recalled by American RegentAtropine Sulfate	American Regent	Particulate Matter	Nationwide
24 Jan 2024Drug	CLASS I	Atropine Sulfate Injection, USP 1 mg/ 1 mg/mL), Lifeshield recalledAtropine Sulfate	Pfizer	Particulate Matter	Nationwide
19 Jul 2023Drug	CLASS II	Atropine Sulfate Injection, USP 8 mg per 4 mg per mL) recalledAtropine Sulfate	Accord Healthcare	Particulate Matter	Nationwide
27 Jul 2022Drug	CLASS II	Atropine Sulfate Injection, USP 2 mg/ 4 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
15 Jun 2022Drug	CLASS II	Isopto Atropine (atropine sulfate ophthalmic solution) recalledIsopto Atropine	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
13 Jan 2021Drug	CLASS II	Atropine Sulfate Injection, 8 mg/ 4 mg/mL) Single Dose Syringe recalled	SCA Pharmaceuticals	Sterility	Nationwide
28 Feb 2018Drug	CLASS II	Atropine Sulfate Injection in all strengths, all doses recalled	Pharmedium Services	Sterility	Nationwide
19 Oct 2016Drug	CLASS II	atropine Sulfate Injection, 4 mg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016Drug	CLASS II	atropine Sulfate Injection, 4 mg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
13 Jul 2016Drug	CLASS I	Atropine Sulfate Injection Solution, 4 mg/ 4 mg/mL) recalled	Cantrell Drug	Potency & Assay	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.