NDC 43386-540

Morphine Sulfate 15 mg tablet, film coated, extended release

Where it's made

Factory	Where	Role	Last FDA inspection
Novel Laboratories, Inc.	Somerset, NJ, United States	Makes it, tests it and packages it	Problems found, fixed voluntarilyApr 17, 2026 · 15 inspections, 1 with FDA action

Apr 10, 2019 · Class III · Lupin Somerset
Failed Impurities/Degradation Specifications
Lots: Lot#: S700220, Exp. Apr 30 2019; S700604, Exp. July 31 2019; S800326, Exp. Mar 31 2020
Apr 10, 2019 · Class III · Lupin Somerset
Failed Impurities/Degradation Specifications
Lots: Lot#: S700221, Exp. Apr 30 2019; S700605, Exp. July 31 2019; S800232, Exp. Feb 29 2020.
Apr 10, 2019 · Class III · Lupin Somerset
Failed Impurities/Degradation Specifications
Lots: Lot#: S700222 Exp. Apr 30 2019 ; S800233 Exp, Feb 29 2020
Apr 10, 2019 · Class III · Lupin Somerset
Failed Impurities/Degradation Specifications
Lots: Lot#: S700223 Exp. Apr 30 2019; S800467, Exp. Mar 31 2020.
Apr 10, 2019 · Class III · Lupin Somerset
Failed Impurities/Degradation Specifications
Lots: Lot#: S700224 Exp. Apr 30 2019; S800469 Exp. Mar 31 2020
Aug 23, 2018 · Class III · Lupin 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.
Lots: Lot# S800232, Exp 2/20

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Morphine: every company that makes it
Form: tablet, film coated, extended release, oral
Strength: 15 mg
Approval: ANDA ANDA203602
On the market since: Dec 16, 2015
Package NDCs: 43386-540-01 43386-540-05
Official label: DailyMed (National Library of Medicine), updated Feb 16, 2024

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