Morphine recalls

The FDA has published 147 recalls involving Morphine since 2012. The latest was reported on 26 Aug 2026. Most were for sterility. The Compounding Pharmacy of America has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls147since 2012

Last 12 months2reported

Class I96% of total

Ongoing5latest 26 Aug 2026

Recalls per month, last 24 months

click a bar for that month

1Nov '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 9 6%Class II 127 86%Class III 11 7%

Why morphine is recalled

Companies

The Compounding Pharmacy of America4732%
Pharmedium Services128%
Hartley Medical Center Pharmacy117%
Assurance Infusion117%
SCA Pharmaceuticals64%
Lupin Somerset64%
Pharmakon Pharmaceuticals53%
Central Admixture Pharmacy Services43%

Brands

By year

202611%
202521%
202421%
202353%
2022107%
202143%
2020128%
2019117%
2018117%
201732%

Ongoing morphine recalls

5 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
13 Nov 2024Drug	CLASS II	Morphine Sulfate Extended-Release Tablets 30 mg recalled	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
27 Mar 2024Drug	CLASS II	Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200	Hikma Pharmaceuticals USA	Other	Nationwide

All morphine recalls, newest first

147 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
13 Nov 2024Drug	CLASS II	Morphine Sulfate Extended-Release Tablets 30 mg recalled	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
27 Mar 2024Drug	CLASS II	Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200	Hikma Pharmaceuticals USA	Other	Nationwide
8 Nov 2023Drug	CLASS III	Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine recalledOpium Tincture Deodorized	Edenbridge Pharmaceuticals	Potency & Assay	Nationwide
9 Aug 2023Drug	CLASS II	morphine in 0.9% sodium chloride, 30 mg/, (1 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	morphine in 0.9% Sodium Chloride, 50 mg/ (1mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	morphine in 0.9% sodium chloride, 1 mg/, (1 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	morphine in 0.9% sodium chloride, 125 mg/, (5 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	Morphine Sulfate Injection, USP, 50 mg/ (1 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	Morphine Sulfate Injection, USP, 2 mg/ (1 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	Morphine Sulfate Injection, USP, 1 mg/mL syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	Morphine Sulfate Injection, USP, 30 mg/ (1 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
20 Jul 2022Drug	CLASS I	Morphine Sulfate extended-Release Tablets recalled	Bryant Ranch Prepack	Packaging Defects	AL
20 Jul 2022Drug	CLASS I	Morphine Sulfate extended-Release Tablets recalled	Bryant Ranch Prepack	Packaging Defects	AL
23 Mar 2022Drug	CLASS II	Morphine Sulfate 6 mg/mL Infusion recalled	Family Pharmacy of Statesville	Sterility	NC
5 Jan 2022Drug	CLASS II	Morphine Sulfate in 0.9% Sodium Chloride Injection recalled by SterRx	SterRx	Sterility	Nationwide
5 Jan 2022Drug	CLASS II	Morphine Sulfate in 5% Dextrose Injection, 100 mg per (1 mg per mL) recalled	SterRx	Sterility	Nationwide
5 Jan 2022Drug	CLASS II	Morphine Sulfate, in 0.9% Sodium Chloride Injection recalled by SterRx	SterRx	Sterility	Nationwide
6 Oct 2021Drug	CLASS II	Morphine Sulfate Injection, USP, 2 mg per mL single dose vial recalledMorphine Sulfate	Fresenius Kabi USA	Sterility	Nationwide
13 Jan 2021Drug	CLASS III	Morphine Sulfate 3 mg/ in 0.9% Sodium Chloride (1mg/mL) CII recalled	SCA Pharmaceuticals	Sterility	Nationwide
13 Jan 2021Drug	CLASS II	Morphine Sulfate 30 mg/ in 0.9% Sodium Chloride (1mg/ml), CII recalled	SCA Pharmaceuticals	Sterility	Nationwide
13 Jan 2021Drug	CLASS II	morphine sulfate 150 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
18 Mar 2020Drug	CLASS II	Morphine Sulfate, 20 mg/mL intrathecal per syringe recalled	Redline Pharmacy Solutions	Other	NE
22 Jan 2020Drug	CLASS II	Morphine 15MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	Morphine 7MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	Morphine 10MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	Morphine 2MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	Morphine 18MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide

Should you stop taking Morphine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.