Lower risk Drug recall · FDA · Published July 16, 2026

Fresenius Kabi Glycopyrrolate Injection Recall: Hair Found in Product

Fresenius Kabi recalls Glycopyrrolate injection vials with hair particles. This may cause allergic reactions or other issues. Stop using and contact your doctor.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0725-2026Drug Fresenius Kabi ›

Lower-risk recall

Presence of Particulate Matter: Hair was found in product

✎ GovInfoNow plain-language explainer

Fresenius Kabi is recalling glycopyrrolate injection vials that contain hair particles. This could cause allergic reactions or other health issues if injected. Read more at govinfonow.com/recall/92411-fresenius-kabi-glycopyrrolate-injection-recall-hair-found-in-product.

Source Summary by GovInfoNow · govinfonow.com/recall/92411-fresenius-kabi-glycopyrrolate-injection-recall-hair-found-in-product · Updated September 23, 2026 · FDA enforcement record: FDA #D-0725-2026

Cite this page

“Fresenius Kabi Glycopyrrolate Injection Recall: Hair Found in Product.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/92411-fresenius-kabi-glycopyrrolate-injection-recall-hair-found-in-product. Based on FDA recall #D-0725-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0725-2026%22&limit=1).

The FDA announced on July 16, 2026, that Fresenius Kabi USA, LLC voluntarily recalled Glycopyrrolate Injection due to the presence of particulate matter, specifically hair found in the product. The recall affects 59,425 vials distributed nationwide.

How to tell if you have it

Brand: Fresenius Kabi
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
NDC Tray: 63323-578-05
NDC Vial: 63323-578-07
Lot #: 6134349, 6134620
Exp. Date: 11/2026

The hazard

According to the FDA, the hazard is the presence of particulate matter, as hair was found in the product.

Context

GovInfoNow's records show Fresenius Kabi USA, LLC has 65 other recalls on record since September 27, 2012. Other recent recalls include a Tyenne Injection recall for glass particles on August 10, 2026, and an Epinephrine Injection recall for failed impurities on May 14, 2026. Similar product recalls include American Regent Nitroglycerin Injection for particulate matter on July 24, 2026, and American Regent Cyanocobalamin Injection for particulate matter on the same date.

How to tell if you have this one

Check for vials labeled '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'. Look for NDC Tray: 63323-578-05 and NDC Vial: 63323-578-07. Lot numbers 6134349 or 6134620 with expiration date 11/2026.

Brand
Fresenius Kabi
Category
Drug

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide within in the USA

Recall number	Product, codes & lots	Quantity
D-0725-2026	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; Lot #: 6134349, 6134620 Exp. Date 11/2026	59,425 vials
D-0726-2026	Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01; Lot #: 6133801, Exp. Date 01/2028	181,225 vials
D-0727-2026	Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05; Lot #: 6133436, Exp. Date 10/2028	92,600 vials
D-0728-2026	Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01; Lot #: 6130235, Exp. Date 02/2027	93,250 vials
D-0729-2026	Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03; Lot #: 6133986, Exp. Date 02/2029	37,250 vials

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the NDC numbers and lot numbers to confirm if your vial is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 13 days after the firm started it.

Jul 16, 2026Firm started the recall
Jul 23, 2026FDA classified it Class II
Jul 29, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Other Fresenius Kabi recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/92411-fresenius-kabi-glycopyrrolate-injection-recall-hair-found-in-product">Fresenius Kabi Glycopyrrolate Injection Recall: Hair Found in Product (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #D-0725-2026 (July 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0725-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.