FDA Drugs recall ·
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL)… recall
- Recall number
- D-0385-2025
- Date
- (initiated April 15, 2025)
- Company / brand
- OurPharma LLC
2512 S City Lake Rd, Fayetteville, AR, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Terminated
- Units affected
- 1,375 cassettes
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
104024120001, Exp Date 06/01/2025; 104024120002, Exp Date 06/21/2025; 104025010001, Exp Date 07/13/2025; 104025010002, Exp Date 07/28/2025
Distribution
Nationwide in the USA
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0385-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.