Recalls / Active ingredient / Morphine Sulfate

Morphine Sulfate

13 FDA drug recalls involving the active ingredient “Morphine Sulfate”.

Date	Class	Product	Firm
2025-11-26	Class III	Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By	Winder Laboratories, LLC
2025-02-06	Class II	Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratori	SUN PHARMACEUTICAL INDUSTRIES INC
2024-03-12	Class II	Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma B	Hikma Pharmaceuticals USA Inc.
2021-09-17	Class II	Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL	Fresenius Kabi USA LLC
2019-04-10	Class III	Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laborator	LUPIN SOMERSET
2019-04-10	Class III	Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laborator	LUPIN SOMERSET
2019-04-10	Class III	Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laborato	LUPIN SOMERSET
2019-04-10	Class III	Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc	LUPIN SOMERSET
2019-04-10	Class III	Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laborator	LUPIN SOMERSET
2018-08-23	Class III	Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratori	LUPIN SOMERSET
2017-06-15	Class II	Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an o	Tris Pharma Inc.
2013-09-16	Class II	Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-	Hospira, Inc.
2012-08-28	Class II	Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LA	Hospira Inc.