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Use caution Drug recall · FDA · Published June 15, 2017

Tris Pharma Morphine Sulfate Oral Solution Leaking Container Recall

Tris Pharma recalls Morphine Sulfate Oral Solution (100mg/5mL) due to leaking container. This medication is prescription-only and may cause overdose if spilled.

🇺🇸 FDA recall #D-1126-2017DrugTris Pharma ›
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Recalling firmTris Pharma Inc.2033 US Highway 130 · Monmouth Junction, NJ 08852-3003
✎ GovInfoNow plain-language explainer

What happened, in plain English

Tris Pharma is recalling Morphine Sulfate Oral Solution because the container leaks. This is dangerous because the medication could spill and cause overdose if not handled properly. Read more at govinfonow.com/recall/41561-tris-pharma-morphine-sulfate-oral-solution-leaking-container-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/41561-tris-pharma-morphine-sulfate-oral-solution-leaking-container-recall · Updated October 8, 2026 · FDA enforcement record: FDA #D-1126-2017

Cite this page

“Tris Pharma Morphine Sulfate Oral Solution Leaking Container Recall.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41561-tris-pharma-morphine-sulfate-oral-solution-leaking-container-recall. Based on FDA recall #D-1126-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1126-2017%22&limit=1).

Why it’s dangerous

The container leaks, which means the medication could spill. If spilled, the solution might cause overdose if it comes into contact with the mouth or is ingested accidentally.

Who’s affected

Prescription patients who own the recalled Morphine Sulfate Oral Solution. Those with the specific lot numbers and expiration dates are most at risk.

How to tell if you have this one

Check for the product name 'Morphine Sulfate Oral Solution', 100 mg/5 mL (20 mg/mL), in a 1 oz. bottle with 30 mL. Look for lot numbers 08215001A, 08215002A, or 08215004A with expiration dates 6/30/2017 or 7/31/2017.

  • Brand
    Tris Pharma
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Container for Leaks

    Inspect the bottle for signs of leakage. If leaking, stop using the product immediately.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

1. Firm started the recall: Jun 15, 201712. FDA classified it Class II: Aug 29, 201723. Published in FDA’s Enforcement Report: Sep 6, 201734. FDA terminated the recall: Nov 8, 201742017
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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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-1126-2017 (June 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1126-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on October 8, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA