HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL) recall
FDA recall D-0385-2025 · initiated Apr 15, 2025
OurPharma LLC recalled HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL) in Apr 2025 — an FDA Class III recall (D-0385-2025) because Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
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..
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,375 cassettes
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
Frequently asked
- Was HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL) recalled?
- OurPharma LLC recalled HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL) in Apr 2025 — an FDA Class III recall (D-0385-2025) because Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification.. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL) recalled?
- Per the FDA enforcement record, the reason for recall D-0385-2025 was: Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
- Is a recalled HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL) are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — 104024120001, Exp Date 06/01/2025; 104024120002, Exp Date 06/21/2025; 104025010001, Exp Date 07/13/2025; 104025010002, Exp Date 07/28/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0385-2025.