MORPHINE SULFATE

Generic: MORPHINE SULFATE

HospiraManufacturer
EPIDURAL, INTRATHECAL, INTRAVENOUSRoute
MORPHINE SULFATEActive Substance
1992-09-30Original Approval

MORPHINE SULFATE is FDA application ANDA073510, sponsored by HOSPIRA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2019-04-10
Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.

Failed Impurities/Degradation Specifications

Class III2019-04-10
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.

Failed Impurities/Degradation Specifications

Class II2021-09-17
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC

Defective container: Cracked vials leading to lack of sterility assurance

Class III2018-08-23
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. S

Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being re

Class III2025-11-26
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in

Class III2019-04-10
Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset

Failed Impurities/Degradation Specifications

Class III2019-04-10
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.

Failed Impurities/Degradation Specifications

Class II2012-08-28
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST,

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial

Class II2017-06-15
Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syring

Defective container: Oral solution leaking from container.

Class II2025-02-06
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., N

Failed Dissolution Specifications

Top Reported Reactions

1
DRUG DEPENDENCE
10,490 reports
2
DRUG HYPERSENSITIVITY
10,119 reports
3
PAIN
9,173 reports
4
OVERDOSE
7,764 reports
5
EMOTIONAL DISTRESS
5,177 reports
6
DEPENDENCE
4,675 reports
7
NAUSEA
4,621 reports
8
DRUG INEFFECTIVE
4,385 reports
9
DEATH
4,211 reports
10
DRUG WITHDRAWAL SYNDROME
3,364 reports