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Class II · ModerateActive recall

Glycopyrrolate

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

Does this affect you?
Check your lot numberLot #: 6134349, 6134620 Exp. Date 11/2026
Where it was soldNationwide within in the USA
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: Hair was found in product

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 byFresenius Kabi USA, LLC
Brand nameGLYCOPYRROLATE
Generic nameGLYCOPYRROLATE
Active ingredient(s)GLYCOPYRROLATE
Distributed by / forFresenius Kabi USA, LLC
Show the full FDA record
Full product labelGlycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07
Recalling firmFresenius Kabi USA, LLC
DistributionNationwide within in the USA
Quantity59,425 vials
Recall initiated2026-07-16
Report date2026-07-29
Recall completed—
Recall numberD-0725-2026
ClassificationClass II
FDA statusOngoing
Origin on fileLake Zurich IL United States

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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.