FDA-Drug2026-08-26Class IIPROCESSING DEFECT
American Regent Atropine Sulfate injection recalled for particulate contamination
What this means
American Regent's Atropine Sulfate injection (1 mg/mL) has been found to contain particulate matter, including hair, glass, and/or paraformaldehyde. The contamination affects specific lot 24353 (expiration 9/30/2026). This is a prescription injectable medication used in hospitals and clinical settings.
- If you dispense or administer this medication, check your inventory for lot 24353 with expiration 9/30/2026.
- Do not use vials from this lot.
- Contact American Regent or your supplier for return or replacement instructions.
- Notify your pharmacy, hospital, or medical facility if you have received vials from this lot.
The agency's original wording
Hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
89,775 vials
Manufactured in
5 Ramsay Rd, Shirley, NY, United States
Products
Atropine 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0795-2026More American Regent recalls
- FDA-Drug2026-09-16American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-PR2026-09-03American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-Drug2026-08-26American Regent Cyanocobalamin injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent Tralement trace elements injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent aminocaproic acid injection recalled for particulate contamination
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