FDA Drugs recall ·
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL)… recall
- Recall number
- D-0725-2026
- Date
- (initiated July 16, 2026)
- Company / brand
- Fresenius Kabi USA, LLC
3 Corporate Dr, Lake Zurich, IL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 59,425 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Presence of Particulate Matter: Hair was found in product
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 6134349, 6134620 Exp. Date 11/2026
Distribution
Nationwide within in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0725-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.