# FDA recall D-0385-2025

> **OurPharma LLC** · Class III · drug recall initiated 2025-04-15.

## Product

HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701,  NDC 73013-1040-01.

## Reason for recall

Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0385-2025
- **Recalling firm:** OurPharma LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2025-04-15
- **Report date:** 2025-04-30
- **Termination date:** 2026-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fayetteville, AR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0385-2025

## Citation

> AI Analytics. FDA recall D-0385-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0385-2025. Source: US FDA. Licensed CC0.

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