American Regent recalls aminocaproic acid injection due to contamination with hair, glass, and paraformaldehyde. This poses a risk of serious injury during IV infusion. Consumers should contact the manufacturer for details.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent has recalled a specific aminocaproic acid injection product because it contains harmful particles like hair, glass, and paraformaldehyde. Using this product could cause serious injury during IV infusion. Affected users should stop using it and contact the manufacturer.
The injection product contains particles such as hair, glass, and paraformaldehyde. These particles can cause serious injury when administered through IV infusion, potentially leading to tissue damage or other complications.
Patients receiving IV infusions of this medication are affected. Those with the specific lot number and expiration date are at highest risk.
Check for the product name 'Aminocaproic Acid Injection, USP, 250 mg/mL (5 g/20 mL)' in 20 mL multiple-dose vials (NDC 0517-9120-01) or 25x20 mL vials (NDC 0517-9120-25). The lot number 24299 and expiration date 8/31/2026 are associated with this recall.
Immediately stop using the recalled aminocaproic acid injection product as it contains harmful particles that could cause serious injury.
No, this product is recalled due to contamination with particles that can cause serious injury during IV infusion.
Stop using it immediately and contact American Regent for further instructions.
The lot number is 24299, with an expiration date of 8/31/2026.
We’ve drafted a message you can send American Regent to request your refund or repair — edit it as you like.
Subject: Recall D-0794-2026 — American Regent American Regent Hello, I own a American Regent that is covered by recall D-0794-2026 from American Regent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.