Morphine Sulfate recalls
Morphine Sulfate products have been recalled 12 times, most recently on 26 Aug 2026. The recalling company is usually Lupin Somerset. The most common reason is potency & assay.
Total recalls12since 2013
Last 12 months2reported
Class I18% of total
Ongoing3latest 26 Aug 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 1 8%Class II 4 33%Class III 7 58%
Why morphine sulfate is recalled
Companies
Product types
By year
Ongoing morphine sulfate recalls
3 active| 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 |
All morphine sulfate recalls, newest first
12 totalAbout this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.