Glycopyrrolate Injection — Class II drug recall D-0725-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2026-07-29, distributed nationwide. Presence of Particulate Matter: Hair was found in product
| Recall number | D-0725-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2026-07-16 |
| Classified | 2026-07-23 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 59,425 vials |
| Reason classes | specification failure |
| NDC | 63323-0578, 63323-0578-01, 63323-0578-02, 63323-0578-03, 63323-0578-04, 63323-0578-05, 63323-0578-07, 63323-0578-18, 63323-0578-20 |
| Lot numbers | 6134349, 6134620 |
| Expiration dates | 2026-11 |
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
Reason for recall
Presence of Particulate Matter: Hair was found in product
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0725-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.