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Class II · ModerateActive recall

Atropine Sulfate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 24353, Exp. Date: 9/30/2026.
Where it was soldNationwide within the U.S
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmerican Regent, Inc.
Brand nameATROPINE SULFATE
Generic nameATROPINE SULFATE
Active ingredient(s)ATROPINE SULFATE
Distributed by / forAmerican Regent, Inc.
NDC0517-1001-01
Show the full FDA record
Full product labelAtropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967.
Recalling firmAmerican Regent, Inc.
DistributionNationwide within the U.S
Quantity89,775 vials
Recall initiated2026-07-24
Report date2026-08-26
Recall completed—
Recall numberD-0795-2026
ClassificationClass II
FDA statusOngoing
Origin on fileShirley NY United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.