Infumorph — Class II drug recall D-0392-2024
Ongoing recall by Hikma Pharmaceuticals USA Inc., reported 2024-03-27, distributed nationwide. The filter included in the carton has an expiration date that has expired prior to the expiration date of the
| Recall number | D-0392-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ, United States |
| Recall initiated | 2024-03-12 |
| Classified | 2024-03-21 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 22,644 ampuls |
| NDC | 00641-6039, 00641-6039-01, 00641-6040, 00641-6040-01 |
| Lot numbers | 023012, 023014, 052001, 052003 |
| Expiration dates | 2024-08, 2024-11 |
Product
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
Reason for recall
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
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-0392-2024. 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.