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
USGlycopyrrolate 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 Firm: Fresenius Kabi USA, LLC
Reason for Recall / Hazard
Presence of Particulate Matter: Hair was found in product
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Lake Zurich |
| State | IL |
| Openfda › Upc › 1 | 0363323578046 |
| Openfda › Upc › 2 | 0363323578039 |
| Openfda › Upc › 3 | 0363323578077 |
| Openfda › Unii | V92SO9WP2I |
| Openfda › Route › 1 | INTRAMUSCULAR |
| Openfda › Route › 2 | INTRAVENOUS |
| Openfda › Rxcui › 1 | 238212 |
| Openfda › Rxcui › 2 | 1731582 |
| Openfda › Rxcui › 3 | 1731590 |
| Openfda › Spl id | 779dc924-ecc3-41cc-8cf9-a7354db4f763 |
| Openfda › Brand name | GLYCOPYRROLATE |
| Openfda › Spl set id | 54458620-d888-4df6-ae4b-78c3dfed3423 |
| Openfda › Package ndc › 1 | 63323-578-03 |
| Openfda › Package ndc › 2 | 63323-578-01 |
| Openfda › Package ndc › 3 | 63323-578-04 |
| Openfda › Package ndc › 4 | 63323-578-02 |
| Openfda › Package ndc › 5 | 63323-578-07 |
| Openfda › Package ndc › 6 | 63323-578-05 |
| Openfda › Package ndc › 7 | 63323-578-18 |
| Openfda › Package ndc › 8 | 63323-578-20 |
| Openfda › Product ndc | 63323-578 |
| Openfda › Generic name | GLYCOPYRROLATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | GLYCOPYRROLATE |
| Openfda › Manufacturer name | Fresenius Kabi USA, LLC |
| Openfda › Application number | ANDA209328 |
| Openfda › Is original packager | true |
| Event id | 99449 |
| Address 1 | 3 Corporate Dr |
| Address 2 | N/A |
| Code info | Lot #: 6134349, 6134620 Exp. Date 11/2026 |
| Postal code | 60047-8930 |
| Report date | 20260729 |
| Product type | Drugs |
| Product quantity | 59,425 vials |
| Reason for recall | Presence of Particulate Matter: Hair was found in product |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260716 |
| Initial firm notification | Letter |
| Center classification date | 20260723 |
Check Other Products In Your Household
Free Safety ToolsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Overview
- Recalling FirmFresenius Kabi USA, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within in the USA
📢 Share Warning
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Fresenius Kabi USA, LLC - 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 Check if your household is affected: https://therecallfile.com/recalls/glycopyrrolate-injection-usp-1-mg-per-5-ml-0-2-mg-per-ml-25-x-5-ml-fil/FDA-D-0725-2026
Join Alertlist
Get instant email updates whenever critical safety recalls like this are published.
Featured on Product Hunt
Help support our public safety mission and check out our community launch.
Support The Recall File
Help keep official recall alerts free, accessible, and fast for everyone.
Related Recalls
UKMHRA Safety Roundup: August 2026
MHRA Safety Roundup: August 2026
Summary of the latest safety advice for medicines and medical device users...
AustraliaCAROTONE skin-brightening products found to contain undeclared prescription-only medicine
CAROTONE skin-brightening products found to contain undeclared prescription-only medicine
We are advising consumers that CAROTONE products marketed for skin brightening may pose a serious risk to your health and should not be used....
UKClass 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles....