Glycopyrrolate Injection recall
FDA recall D-0725-2026 · initiated Jul 16, 2026
Fresenius Kabi USA, LLC recalled Glycopyrrolate Injection in Jul 2026 — an FDA Class II recall (D-0725-2026) because Presence of Particulate Matter: Hair was found in product.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter: Hair was found in product
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 59,425 vials
Details
- Product
- Glycopyrrolate 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 company
- Fresenius Kabi USA LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within in the USA
- Initiated
- Jul 16, 2026
- FDA report date
- Jul 29, 2026
Frequently asked
- Was Glycopyrrolate Injection recalled?
- Fresenius Kabi USA, LLC recalled Glycopyrrolate Injection in Jul 2026 — an FDA Class II recall (D-0725-2026) because Presence of Particulate Matter: Hair was found in product. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Glycopyrrolate Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0725-2026 was: Presence of Particulate Matter: Hair was found in product
- Is a recalled Glycopyrrolate Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Glycopyrrolate Injection are affected?
- Distributed: Nationwide within in the USA. The recall covers these lots — Lot #: 6134349, 6134620 Exp. Date 11/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0725-2026.