CLASS II Drug recall · Reported 6 Sep 2017 · FDA Enforcement Report
Morphine Sulfate Oral Solution, 100 mg/ (20 mg/mL) recalled
Tris Pharma is recalling Morphine Sulfate Oral Solution, 100 mg/ (20 mg/mL), distributed nationwide in the US. The recall was initiated on 15 Jun 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1126-2017
- FDA event ID
- 77798
- Recalling firm
- Tris Pharma, Monmouth Junction, NJ
- Brand
- Morphine Sulfate
- Manufacturer
- Cranbury Pharmaceuticals, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2017
- FDA classified
- 29 Aug 2017
- Reported
- 6 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 15 Jun 2017 | Recall initiated by company | |
| 29 Aug 2017 | Classified by FDA | +75 days |
| 6 Sep 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: Oral solution leaking from container.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Defective container: Oral solution leaking from container.
Which lots are affected?
Lot #: 08215001A, Exp 6/30/2017; 08215002A, 08215004A, Exp 7/31/2017
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Tris Pharma
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocodone Polistirex and Chlorpheniramine Polistirex recalledHydrocodone Polistirex And Chlorpheniramine Polistirex | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | infants* Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
Other Morphine recalls
All 147| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Morphine Sulfate Oral Solution 100 mg / (20 mg* / mL) recalledMorphine Sulfate | Winder Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets 30 mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200 | Hikma Pharmaceuticals USA | Other | Nationwide |