# FDA recall D-0392-2024

> **Hikma Pharmaceuticals USA Inc.** · Class II · drug recall initiated 2024-03-12.

## 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.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0392-2024
- **Recalling firm:** Hikma Pharmaceuticals USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-03-12
- **Report date:** 2024-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cherry Hill, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0392-2024

## Citation

> AI Analytics. FDA recall D-0392-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0392-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*