Pharmakon Morphine Recall: Potency Hazard
Pharmakon recalls one lot of compounded Morphine Sulfate injection due to high potency. Check your syringe details immediately.
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Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
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What happened, in plain English
Pharmakon Pharmaceuticals is recalling one lot of compounded Morphine Sulfate 0.5 mg/mL injection because it was found to be out of specification for potency, specifically having higher than intended strength. This product is a Class I recall, indicating the highest risk category. The affected item is a preservative-free syringe containing 0.9% Sodium Chloride. Read more at govinfonow.com/recall/43163-pharmakon-morphine-recall-potency-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/43163-pharmakon-morphine-recall-potency-hazard · Updated October 11, 2026 · FDA enforcement record: FDA #D-0871-2016
Cite this page
“Pharmakon Morphine Recall: Potency Hazard.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43163-pharmakon-morphine-recall-potency-hazard. Based on FDA recall #D-0871-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0871-2016%22&limit=1).
Why it’s dangerous
The recalled syringe contains a higher concentration of morphine than labeled, which can lead to accidental overdose if the standard dose is administered. High-potency opioids carry significant risks including respiratory depression and death.
Who’s affected
Patients in Indiana and Illinois who received this specific compounded drug from Pharmakon Pharmaceuticals are likely affected. Individuals using this medication for pain management or other medical purposes face the highest risk due to the potency error.
How to tell if you have this one
Check for Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL. Look for NDC 45183-0322-78 and Lot # E52418EV11C with an expiration date of 03/19/2016.
- Brand
Pharmakon Pharmaceuticals- Category
Drug
What to do — step by step
Stop Using the Medication
Do not administer the recalled syringe due to the risk of overdose from high potency.
Contact Your Healthcare Provider
Reach out to your doctor or pharmacist immediately for guidance on alternative treatment options.
Where it went and when
Where it was distributed
Distributed in Illinois and Indiana.
FDA distribution: “IN and IL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Indiana.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for this recall?
The National Drug Code (NDC) is 45183-0322-78.
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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-0871-2016 (February 11, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0871-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.