Morphine Sulfate Injection — Class II drug recall D-0856-2021
Terminated recall by Fresenius Kabi USA LLC, reported 2021-10-06, distributed nationwide. Defective container: Cracked vials leading to lack of sterility assurance
| Recall number | D-0856-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA LLC, Melrose Park, IL, United States |
| Recall initiated | 2021-09-17 |
| Classified | 2021-09-27 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2023-06-20 |
| Distributed | Nationwide (US) |
| Quantity | 963,000 vials |
| Reason classes | sterility, packaging |
| NDC | 63323-0451, 63323-0451-00, 63323-0451-01, 63323-0452, 63323-0452-00, 63323-0452-01, 63323-0454, 63323-0454-00, 63323-0454-01, 63323-0455, 63323-0455-00, 63323-0455-01, 63323-0458, 63323-0458-00, 63323-0458-01 |
| Lot numbers | 6023731, 6023732, 6024172, 6024260 |
| Expiration dates | 2023-03, 2023-06 |
Product
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper
Reason for recall
Defective container: Cracked vials leading to lack of sterility assurance
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-0856-2021. 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.