FDAClass IIIApril 30, 2025

HYDROmorphone Hydrochloride 50mg/50mL recall: Superpotent

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.

Why was HYDROmorphone Hydrochloride 50mg/50mL recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

104024120001, Exp Date 06/01/2025; 104024120002, Exp Date 06/21/2025; 104025010001, Exp Date 07/13/2025; 104025010002, Exp Date 07/28/2025

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 firm
OurPharma LLC
Quantity
1,375 cassettes
Distribution
Nationwide in the USA
Recall date
April 30, 2025
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls