FDA Drug recall D-0385-2025
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville,…
- FDA Drug
- Class III
- terminated
- Published 2025-04-30
On 2025-04-30 the FDA classified a Class III recall of HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville,… by Ourpharma, citing superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0385-2025 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2025-04-15 |
| Published | 2025-04-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ourpharma |
| Distribution | US |
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
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Identifiers
| code_info | 104024120001, Exp Date 06/01/2025; 104024120002, Exp Date 06/21/2025; 104025010001, Exp Date 07/13/2025; 104025010002, Exp Date 07/28/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Ourpharma
- fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville,…
FDA Drug · Class II · 2026-09-16 · Ourpharma - FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. C…
FDA Drug · Class III · 2023-02-01 · Ourpharma - FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma…
FDA Drug · Class II · 2022-12-21 · Ourpharma
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0385-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.