HYDROmorphone Hydrochloride 50mg/50mL — Class III drug recall D-0385-2025
Terminated recall by OurPharma LLC, reported 2025-04-30, distributed nationwide. Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than s
| Recall number | D-0385-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OurPharma LLC, Fayetteville, AR, United States |
| Recall initiated | 2025-04-15 |
| Classified | 2025-04-21 |
| Reported by FDA | 2025-04-30 |
| Terminated | 2026-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 1,375 cassettes |
| Reason classes | potency, specification failure |
| NDC | 73013-1040-01 |
| Expiration dates | 2025-06-01, 2025-06-21, 2025-07-13, 2025-07-28 |
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..
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-0385-2025. 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.