PharMEDium Services, LLC. recalls Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium
PharMEDium recalls 0.5 mg/mL hydromorphone injections due to potency errors. This may cause overdose risks. Check NDC 61553-352-40 and lot number 172820134M.
Use caution until it’s fixed
Superpotent drug: out of specification result for potency
Contact the company & request your remedy
What happened, in plain English
PharMEDium is recalling hydromorphone injections that may have incorrect potency levels. This could lead to overdose risks if used as intended. Read more at govinfonow.com/recall/41138-pharmedium-hydromor-potency-issue-in-pain-medication.
Source Summary by GovInfoNow · govinfonow.com/recall/41138-pharmedium-hydromor-potency-issue-in-pain-medication · Updated October 7, 2026 · FDA enforcement record: FDA #D-0080-2018
Cite this page
“PharMEDium Hydromor: Potency Issue in Pain Medication.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41138-pharmedium-hydromor-potency-issue-in-pain-medication. Based on FDA recall #D-0080-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0080-2018%22&limit=1).
Why it’s dangerous
The hydromorphone injections may have potency levels outside the specified range. This could result in an overdose if the medication is used as directed, especially in sensitive patients.
Who’s affected
Prescription pain medication users who have the specific hydromorphone injection product with NDC 61553-352-40 and lot number 172820134M. Healthcare providers and patients using this medication are most at risk.
How to tell if you have this one
Check for the NDC code 61553-352-40 and lot number 172820134M on the syringe packaging. This product is sold under PharMEDium Services, LLC.
- Brand
PharMEDium- Category
Drug
What to do — step by step
Check Product Details
Look for NDC 61553-352-40 and lot number 172820134M on the syringe packaging.
Questions people ask
Is this product safe to use?
The recall states the product may have incorrect potency levels, which could lead to overdose risks. Do not use this specific product without checking with the manufacturer.
What should I do if I have this product?
The recall does not specify a remedy, so contact PharMEDium Services, LLC directly for guidance.
How can I verify if I have the recalled product?
Check the NDC code 61553-352-40 and lot number 172820134M on the syringe packaging.
Contact PharMEDium
We’ve drafted a message you can send PharMEDium to request your refund or repair — edit it as you like.
Subject: Recall D-0080-2018 — PharMEDium PharMEDium Hello, I own a PharMEDium that is covered by recall D-0080-2018 from PharMEDium. 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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Where this comes from
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.
- Official source: FDA Recall #D-0080-2018 (October 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0080-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.