Atropine Sulfate recalls

Atropine Sulfate products have been recalled 4 times, most recently on 26 Aug 2026. The recalling company is usually Accord Healthcare. The most common reason is particulate matter.

Total recalls4since 2023

Last 12 months1reported

Class I125% of total

Ongoing2latest 26 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 1Jan '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 1 25%Class II 2 50%Class III 1 25%

Why atropine sulfate is recalled

Particulate Matter375%
Potency & Assay125%

Companies

Product types

Injectable & IV Drugs375%
Eye Drops125%

By year

2026125%
2025125%
2024125%
2023125%

Ongoing atropine sulfate 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 sulfate recalls, newest first

4 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
8 Jan 2025Drug	CLASS III	Atropine Sulfate Ophthalmic Solution recalled by Somerset TherapeuticsAtropine Sulfate	Somerset Therapeutics	Potency & Assay	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

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.