Quick answers
- What is Morphine sulfate used for?
- The FDA-approved label (MS Contin, Rhodes Pharmaceuticals LLC, August 14, 2026) says: “MS CONTIN is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Morphine sulfate have a boxed warning?
- Yes. The FDA label for MS Contin has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MS CONTIN”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Morphine sulfate?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
- Has Morphine sulfate been recalled?
- FDA enforcement reports list 13 recalls of products of this medicine; the newest started August 4, 2026 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Morphine sulfate?
- 24 companies list prescription products of Morphine sulfate in the FDA NDC Directory, including Bryant Ranch Prepack, Hikma Pharmaceuticals USA Inc. and Fresenius Kabi USA, LLC.
What Morphine sulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MS CONTIN is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. …
— FDA label: MS Contin, Rhodes Pharmaceuticals LLC, effective August 14, 2026. Read the full label on DailyMed →
The FDA has 65 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MS CONTIN
. Read it on the full label →
65 of 65 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated, extended release · Solution · Capsule, extended release · Injection, solution · Tablet · Injection · Tablet, extended release |
|---|---|
| Route | Oral · Intravenous · Intramuscular · Epidural · Intrathecal |
| Prescription products | 141 in the FDA NDC Directory |
| Brand names | Ms Contin, Mitigo, Duramorph, Infumorph 200, Infumorph 500 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| morphine sulfate 10 mg capsule, extended release | Generic | $2.61 per capsule |
| morphine sulfate 10 mg/5 mL solution | Generic | $0.0421–$0.0921 per mL 4 packages, lowest to highest |
| morphine sulfate 10 mg/mL injection | Generic | $2.34 per mL |
| morphine sulfate 100 mg tablet, extended release | Generic | $0.8556 per tablet |
| morphine sulfate 100 mg tablet, film coated, extended release | Generic | $0.8556 per tablet |
| morphine sulfate 100 mg/5 mL solution | Generic | $0.2977–$0.4591 per mL 6 packages, lowest to highest |
| morphine sulfate 15 mg tablet | Generic | $0.2227 per tablet |
| morphine sulfate 15 mg tablet, extended release | Generic | $0.3100 per tablet |
| morphine sulfate 15 mg tablet, film coated, extended release | Generic | $0.3100 per tablet |
| morphine sulfate 15 mg tablet, film coated, extended release | Brand: MS Contin | $4.65 per tablet |
| morphine sulfate 20 mg capsule, extended release | Generic | $3.08 per capsule |
| morphine sulfate 20 mg/5 mL solution | Generic | $0.1205 per mL |
| morphine sulfate 20 mg/mL solution | Generic | $0.2977–$0.4591 per mL 5 packages, lowest to highest |
| morphine sulfate 200 mg tablet, extended release | Generic | $2.21 per tablet |
| morphine sulfate 200 mg tablet, film coated, extended release | Generic | $2.21 per tablet |
| morphine sulfate 30 mg tablet | Generic | $0.3545 per tablet |
| morphine sulfate 30 mg tablet, extended release | Generic | $0.4290 per tablet |
| morphine sulfate 30 mg tablet, film coated, extended release | Generic | $0.4290 per tablet |
| morphine sulfate 30 mg tablet, film coated, extended release | Brand: MS Contin | $8.95 per tablet |
| morphine sulfate 4 mg/mL injection | Generic | $2.32 per mL |
| morphine sulfate 60 mg tablet, extended release | Generic | $0.6949 per tablet |
| morphine sulfate 60 mg tablet, film coated, extended release | Generic | $0.6949 per tablet |
NADAC list of November 4, 2026; these prices took effect between June 17, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack22 products
- Hikma Pharmaceuticals USA Inc.14 products
- Fresenius Kabi USA, LLC11 products
- American Health Packaging10 products
- Upsher-Smith Laboratories, LLC9 products
- SpecGx LLC8 products
- Rhodes Pharmaceuticals LLC8 products
- Amneal Pharmaceuticals of New York LLC7 products
- Hospira, Inc.6 products
- Nortec Development Associates, Inc.6 products
- Actavis Pharma, Inc.6 products
- Precision Dose, Inc.6 products
- Lupin Pharmaceuticals, Inc.5 products
- Sun Pharmaceutical Industries, Inc.5 products
- Major Pharmaceuticals4 products
- Winder Laboratories LLC3 products
- Piramal Critical Care Inc2 products
- Redpharm Drug2 products
- Ascend Laboratories, LLC2 products
- PAI Holdings, LLC dba PAI Pharma2 products
- International Medication Systems, Limited1 product
- St. Mary's Medical Park Pharmacy1 product
- Civica, Inc.1 product
- Cranbury Pharmaceuticals, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018565 DURAMORPH PF, INFUMORPH | Hikma | September 18, 1984 | 23, latest December 22, 2025 2025: Labeling · 2025: Labeling · 2023: Labeling |
| NDA019516 MS CONTIN | Knoa Pharma | May 29, 1987 | 40, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
| NDA022195 MORPHINE SULFATE | Hikma | March 17, 2008 | 18, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
| NDA022207 MORPHINE SULFATE | Hikma | March 17, 2008 | 12, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
| NDA202515 MORPHINE SULFATE | Hospira Inc | November 14, 2011 | 8, latest December 22, 2025 2025: Labeling · 2023: Labeling · 2022: Labeling |
| NDA204223 MORPHINE SULFATE | Fresenius Kabi USA | October 30, 2013 | 9, latest May 29, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
Generic approvals (23)
- ANDA073509Hospira · September 30, 1992
- ANDA073510Hospira · September 30, 1992
- ANDA074769Rhodes Pharms · July 2, 1998
- ANDA074862Rhodes Pharms · July 7, 1998
- ANDA076438Specgx LLC · July 3, 2003
- ANDA076412Specgx LLC · July 31, 2003
- ANDA202348Specgx LLC · July 15, 2011
- ANDA078761Sun Pharm Inds Ltd · May 11, 2012
- ANDA079040Actavis Elizabeth · January 16, 2013
- ANDA202104Upsher Smith Labs · June 3, 2013
- ANDA203518Tris Pharma Inc · May 12, 2015
- ANDA205758Hikma · May 21, 2015
- ANDA203602Novel Labs Inc · December 16, 2015
- ANDA200411Impax Labs Inc · April 12, 2016
- ANDA206573Pharm Assoc · November 14, 2016
- ANDA204393Piramal Critical · July 16, 2018
- ANDA210610Upsher Smith Labs · July 22, 2019
- ANDA212451Alkem Labs Ltd · December 3, 2020
- ANDA211454Winder Labs LLC · February 12, 2021
- ANDA202861Intl Medication Sys · April 29, 2021
- ANDA203158Anda Repository · August 4, 2021
- ANDA211452Hikma · January 12, 2023
- ANDA215194Specgx LLC · August 21, 2023
Shortage status
Current shortage · updated October 21, 2026 · first posted October 31, 2017
| Product | Morphine Sulfate, Injection, 2 mg/1 mL (NDC 0409-1890-23) |
|---|---|
| Availability | Limited Availability |
| Reason given | Other |
| Company | Hospira, Inc., a Pfizer Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 4, 2026 · Class I · Ongoing · D-0788-2026
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale N — Fresenius Kabi USA, LLC
-
November 26, 2025 · Class III · Ongoing · D-0223-2026
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01 — Winder Laboratories, LLC
-
February 6, 2025 · Class II · Ongoing · D-0249-2025
Failed Dissolution Specifications
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC — SUN PHARMACEUTICAL INDUSTRIES INC
-
March 12, 2024 · Class II · Ongoing · D-0392-2024
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01 — Hikma Pharmaceuticals USA Inc.
-
September 17, 2021 · Class II · Terminated · D-0856-2021
Defective container: Cracked vials leading to lack of sterility assurance
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper — Fresenius Kabi USA LLC
-
April 10, 2019 · Class III · Terminated · D-1246-2019
Failed Impurities/Degradation Specifications
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-543- — LUPIN SOMERSET
-
April 10, 2019 · Class III · Terminated · D-1247-2019
Failed Impurities/Degradation Specifications
Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-544-01 — LUPIN SOMERSET
-
April 10, 2019 · Class III · Terminated · D-1243-2019
Failed Impurities/Degradation Specifications
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540- — LUPIN SOMERSET
-
April 10, 2019 · Class III · Terminated · D-1245-2019
Failed Impurities/Degradation Specifications
Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-542-0 — LUPIN SOMERSET
-
April 10, 2019 · Class III · Terminated · D-1244-2019
Failed Impurities/Degradation Specifications
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-541-0 — LUPIN SOMERSET
-
August 23, 2018 · Class III · Terminated · D-1214-2018
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.
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541- — LUPIN SOMERSET
-
June 15, 2017 · Class II · Terminated · D-1126-2017
Defective container: Oral solution leaking from container.
Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01 — Tris Pharma Inc.
-
August 28, 2012 · Class II · Terminated · D-308-2013
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12 — Hospira Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 891874, 891881, 891888, 891893, 892345, 892352, 892473, 892489, 892494, 892554 … (+10) |
|---|---|
| SPL set ID of the quoted label | c354b3bf-86c0-4bb8-8b1f-be2164942698 |
| FDA labels (SPL) | 65 |
| FDA applications | NDA018565, NDA019516, NDA022195, NDA022207, NDA202515, NDA204223, 23 ANDA |
| Active ingredients (FDA) | MORPHINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — MS Contin, Rhodes Pharmaceuticals LLC, effective August 14, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →