FDA-Drug2026-08-26Class IIPROCESSING DEFECT
American Regent aminocaproic acid injection recalled for particulate contamination
What this means
American Regent's aminocaproic acid injection (250 mg/mL) has been recalled because batches contain particulate matter including hair, glass, and/or paraformaldehyde. The contamination affects 20 mL vials distributed nationwide. This is a prescription medication used to control bleeding.
- Check your facility or pharmacy for lot #24299 (expiration 8/31/2026).
- Do not use any vials from this lot.
- Contact your supplier or American Regent for guidance on return or replacement.
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
63,200 vials
Manufactured in
5 Ramsay Rd, Shirley, NY, United States
Products
AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0794-2026More 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 Selenious Acid Injection recalled for particulate contamination
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