OurPharma LLC recalls 50mL hydrocodone injection with higher-than-stated potency. This may cause overdose if used without proper dilution. Return to pharmacy for replacement.
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
OurPharma LLC is recalling hydrocodone injections that contain more active drug than labeled. This could lead to overdose if used without careful dilution, especially for patients on regular pain management.
The compounded hydrocodone solution has higher-than-stated potency due to assay errors. This means a smaller dose could cause overdose if not diluted correctly for the intended use.
Patients prescribed hydrocodone injections by a doctor. Those using the product without proper dilution are at higher risk of overdose.
Look for the 50mL cassette labeled 'HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL)' with NDC 73013-1040-01 or similar numbers. Products were sold in Fayetteville, AR starting from 2023.
Verify the product label matches the recalled NDC numbers listed in the recall notice.
Return the product to your pharmacy for a replacement with the correct potency.
No, the product contains higher-than-stated potency which could cause overdose if not diluted correctly.
Check for the NDC numbers 73013-1040-01, 104024120001, 104024120002, 104025010001, or 104025010002 on the label.
Return it to your pharmacy for a replacement with the correct potency.
We’ve drafted a message you can send OurPharma to request your refund or repair — edit it as you like.
Subject: Recall D-0385-2025 — OurPharma OurPharma Hello, I own a OurPharma that is covered by recall D-0385-2025 from OurPharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
