The FDA has posted an ongoing Class II recall of atropine sulfate injection USP 1 mg/mL from American Regent, covering single-dose vials and cartons. The stated reason is particulate matter identified as hair, glass and/or paraformaldehyde.
This is a resuscitation drug, which changes how the recall lands. Atropine is not something drawn up at leisure from a considered prescription; it is drawn from a crash trolley or an airway box under time pressure, often by whoever is nearest, in poor light, with a patient bradycardic in front of them. Glass particulate in an intravenous injection is a real hazard, and the circumstances of use make visual inspection least likely to happen.
The action is an inventory one rather than a bedside one. Someone has to check what is on the trolleys and in the rapid-sequence induction boxes against the affected lots, because nobody will do that at the moment of use.
Note also what the recall does not mean. There is no suggestion that atropine should be withheld or that an alternative agent should be substituted in an emergency; the product defect is a manufacturing one confined to specific lots.
- Check crash trolleys, airway boxes and anaesthetic drawers against the affected lots — not just the pharmacy shelf
- Continue to inspect ampoules and vials against the light before drawing up, as standard practice
- Do not withhold atropine in an emergency over this; it concerns specific lots, not the drug
- Record where replacement stock has been placed, so the next team finds it where they expect it
The statistics, in plain English
Class II is the FDA's middle recall category: exposure may cause temporary or medically reversible harm, with a remote probability of serious consequences. Status is listed as ongoing, meaning affected stock may still be in circulation and the recall has not been completed.
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