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 month

0Nov '24 0 0 0Feb 1 0 0May 0 0 0Aug 0 0 0Nov 1 0 0Feb 0 0 0May 0 0 1Aug 0 0

Severity split

Class I 1 8%Class II 4 33%Class III 7 58%

Why morphine sulfate is recalled

Companies

Product types

Pain Medication12100%

By year

202618%
2025217%
202118%
2019542%
201818%
201718%
201318%

Ongoing morphine sulfate recalls

3 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS I	Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate	Fresenius Kabi USA	Packaging Defects	Nationwide
17 Dec 2025Drug	CLASS III	Morphine Sulfate Oral Solution 100 mg / (20 mg* / mL) recalledMorphine Sulfate	Winder Laboratories	Packaging Defects	Nationwide
12 Mar 2025Drug	CLASS II	Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide

All morphine sulfate recalls, newest first

12 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS I	Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate	Fresenius Kabi USA	Packaging Defects	Nationwide
17 Dec 2025Drug	CLASS III	Morphine Sulfate Oral Solution 100 mg / (20 mg* / mL) recalledMorphine Sulfate	Winder Laboratories	Packaging Defects	Nationwide
12 Mar 2025Drug	CLASS II	Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
6 Oct 2021Drug	CLASS II	Morphine Sulfate Injection, USP, 2 mg per mL single dose vial recalledMorphine Sulfate	Fresenius Kabi USA	Sterility	Nationwide
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 30 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 15 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 200 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 60 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
26 Sep 2018Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 30 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
6 Sep 2017Drug	CLASS II	Morphine Sulfate Oral Solution, 100 mg/ (20 mg/mL) recalledMorphine Sulfate	Tris Pharma	Packaging Defects	Nationwide
8 May 2013Drug	CLASS II	Preservative-Free Morphine Sulfate Injection, USP, 10 mg recalledMorphine Sulfate	Hospira	Sterility	Nationwide

About 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.