American Regent recalls Atropine Sulfate injection (1 mg/mL IV) due to contamination with hair, glass, and paraformaldehyde. This poses a risk of serious injury if injected. Affected lots: 24353 (expiring 9/30/2026).
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent is recalling Atropine Sulfate injection (1 mg/mL for IV use) because it contains harmful particles like hair, glass, and paraformaldehyde. Using this product could cause serious injury if injected.
The injection contains particles such as hair, glass, and paraformaldehyde. If injected, these particles can cause serious injury or death due to blockages or toxic reactions in the bloodstream.
Healthcare professionals who use this medication for intravenous injections. Patients receiving this drug under medical supervision are at risk if they use the recalled product.
Check for the product name 'Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile' in single-dose vials (NDC 0517-1001-01 or 0517-1001-25). The lot number 24353 expires September 30, 2026.
Immediately discard the recalled Atropine Sulfate injection vials if you have them.
The product contains particulate matter including hair, glass, and paraformaldehyde, which can cause serious injury if injected.
Lot 24353 (expiring September 30, 2026).
Look for the product name and NDC numbers 0517-1001-01 or 0517-1001-25 on single-dose vials.
We’ve drafted a message you can send American Regent to request your refund or repair — edit it as you like.
Subject: Recall D-0795-2026 — American Regent American Regent Hello, I own a American Regent that is covered by recall D-0795-2026 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.
