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Morphine Sulfate

FDA recalls

9 rows

DateCompany and reasonClass
Aug 3, 2026Fresenius Kabi USA, LLC
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.		Class I · Ongoing
Nov 25, 2025Winder Laboratories, LLC
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.		Class III · Ongoing
Feb 5, 2025Sun Pharmaceutical Industries Inc
Failed Dissolution Specifications		Class II · Ongoing
Mar 11, 2024Hikma Pharmaceuticals USA Inc.
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.		Class II · Ongoing
Sep 16, 2021Fresenius Kabi USA LLC
Defective container: Cracked vials leading to lack of sterility assurance		Class II · Terminated
Apr 9, 2019Lupin Somerset
Failed Impurities/Degradation Specifications		Class III · Terminated
Aug 22, 2018Lupin Somerset
Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.		Class III · Terminated
Jun 14, 2017Tris Pharma Inc.
Defective container: Oral solution leaking from container.		Class II · Terminated
Aug 27, 2012Hospira Inc.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial		Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).