Class IIITerminated

HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL) recall

FDA recall D-0385-2025 · initiated Apr 15, 2025

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

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

Details

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.
Recalling company: OurPharma LLC
Classification: Class III
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Apr 15, 2025
FDA report date: Apr 30, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0385-2025 ↗

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