Morphine Sulfate 5 mg per 0 — Class II drug recall D-0254-2025
Ongoing recall by Safecor Health, LLC, reported 2025-03-12, distributed nationwide. Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
| Recall number | D-0254-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Safecor Health, LLC, Columbus, OH, United States |
| Recall initiated | 2025-02-17 |
| Classified | 2025-03-05 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 12,390 oral |
| Reason classes | packaging |
| Expiration dates | 2025-01-23, 2025-02-19, 2025-03-18, 2025-03-19, 2025-03-31, 2025-06-21, 2025-07-17 |
Product
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.
Reason for recall
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
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-0254-2025. 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.