OurPharma LLC recalls HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lak…

Recall date

April 15, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0385-2025

FDA classification

Class III

Brand / firm

OurPharma LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.