Quick answers
- What is Mesalamine used for?
- The FDA-approved label (Rowasa, Viatris Specialty LLC, August 3, 2026) says: “ROWASA is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. ROWASA is an aminosalicylate indicated for treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mesalamine have a boxed warning?
- No. None of the 49 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Mesalamine?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated September 16, 2026). Ask your pharmacist about alternatives.
- Has Mesalamine been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started February 5, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Mesalamine?
- 37 companies list prescription products of Mesalamine in the FDA NDC Directory, including Bryant Ranch Prepack, Takeda Pharmaceuticals America, Inc. and Zydus Lifesciences Limited.
What Mesalamine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ROWASA is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. ROWASA is an aminosalicylate indicated for treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.
— FDA label: Rowasa, Viatris Specialty LLC, effective August 3, 2026. Read the full label on DailyMed →
The FDA has 49 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 49 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| mesalamine 0.375 g capsule, extended release | Generic | $0.4841 per capsule |
| mesalamine 1.2 g tablet, delayed release | Generic | $0.7416 per tablet |
| mesalamine 1.2 g tablet, delayed release | Brand: Lialda | $8.94 per tablet |
| mesalamine 1000 mg suppository | Generic | $1.28 per suppository |
| mesalamine 1000 mg suppository | Brand: Canasa | $37.11 per suppository |
| mesalamine 250 mg capsule | Brand: Pentasa | $2.90 per capsule |
| mesalamine 375 mg capsule, extended release | Generic | $0.4841 per capsule |
| mesalamine 4 g/60 mL enema | Generic | $0.0996–$0.1735 per mL 3 packages, lowest to highest |
| mesalamine 4 g/60 mL suspension | Generic | $0.0996–$0.1735 per mL 3 packages, lowest to highest |
| mesalamine 400 mg capsule, delayed release | Generic | $2.64 per capsule |
| mesalamine 500 mg capsule | Brand: Pentasa | $5.82 per capsule |
| mesalamine 800 mg tablet, delayed release | Generic | $4.32 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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 Prepack5 products
- Takeda Pharmaceuticals America, Inc.4 products
- Zydus Lifesciences Limited4 products
- American Health Packaging4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Camber Pharmaceuticals, Inc.3 products
- Sandoz Inc2 products
- Golden State Medical Supply, Inc.2 products
- Actavis Pharma, Inc.2 products
- ANI Pharmaceuticals, Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Teva Pharmaceuticals USA, Inc.2 products
- Rising Pharma Holdings, Inc.2 products
- Upsher-Smith Laboratories, LLC1 product
- Alembic Pharmaceuticals Limited1 product
- Amring Pharmaceuticals Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Nuvaila Limited1 product
- Major Pharmaceuticals1 product
- AvKARE1 product
- Padagis Israel Pharmaceuticals Ltd1 product
- Ascend Laboratories, LLC1 product
- Chartwell RX, LLC1 product
- Viatris Specialty LLC1 product
- NorthStar RxLLC1 product
- Alembic Pharmaceuticals Inc.1 product
- Mylan Pharmaceuticals Inc.1 product
- Lannett Company, Inc.1 product
- Encube Ethicals, Inc.1 product
- Salix Pharmaceuticals, Inc.1 product
- Teva Pharmaceuticals, Inc.1 product
- KLM Laboratories Private Limited1 product
- NorthStar Rx LLC1 product
- Ingenus Pharmaceuticals, LLC1 product
- Allergan, Inc.1 product
- Aurobindo Pharma Limited1 product
- AvPAK1 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 |
|---|---|---|---|
| NDA019618 ROWASA, SFROWASA | Mylan Speciality LP | December 24, 1987 | 20, latest October 14, 2026 2026: Labeling · 2024: Labeling · 2023: Labeling |
| NDA020049 PENTASA | Takeda Pharms USA | May 10, 1993 | 27, latest October 14, 2026 2026: Labeling · 2024: Labeling · 2023: Labeling |
| NDA021252 CANASA | Abbvie | January 5, 2001 | 18, latest October 14, 2026 2026: Labeling · 2023: Labeling · 2022: Labeling |
| NDA022000 LIALDA | Takeda Pharms USA | January 16, 2007 | 21, latest October 14, 2026 2026: Labeling · 2023: Labeling · 2022: Labeling |
| NDA022301 APRISO | Salix | October 31, 2008 | 10, latest October 14, 2026 2026: Labeling · 2023: Labeling · 2022: Labeling |
Generic approvals (29)
- ANDA076751Padagis Israel · September 17, 2004
- ANDA091640Zydus Pharms · June 5, 2017
- ANDA203286Zydus Pharms · July 21, 2017
- ANDA203817Actavis Labs Fl · March 23, 2018
- ANDA211858Sun Pharm · January 25, 2019
- ANDA207448Rising · April 19, 2019
- ANDA207873Teva Pharms USA · May 9, 2019
- ANDA208362J Molner · June 21, 2019
- ANDA207271Mylan · November 20, 2019
- ANDA208953Zydus Pharms · February 12, 2020
- ANDA213377Annora Pharma · March 19, 2020
- ANDA205654Actavis Mid Atlantic · August 14, 2020
- ANDA214242Alkem Labs Ltd · July 15, 2021
- ANDA208954Zydus Pharms · August 12, 2021
- ANDA214585Sun Pharm · May 11, 2022
- ANDA216967Alembic · October 28, 2022
- ANDA214477Aurobindo Pharma Ltd · March 31, 2023
- ANDA217337Sinotherapeutics Inc · May 12, 2023
- ANDA216941Encube · May 30, 2023
- ANDA217533Amta · June 6, 2023
- ANDA216334Annora Pharma · February 5, 2024
- ANDA213191Teva Pharms Inc · August 22, 2024
- ANDA218410Novast Labs · August 22, 2024
- ANDA215067Amneal · February 18, 2025
- ANDA219028Rising · April 14, 2025
- ANDA215269Novitium Pharma · April 16, 2025
- ANDA219864Annora Pharma · August 13, 2025
- ANDA219997Sandoz · March 10, 2026
- ANDA220016Klm Labs Pvt · March 31, 2026
Shortage status
To be discontinued · updated September 16, 2026 · first posted September 16, 2026
| Product | Pentasa, Capsule, Extended Release, 500 mg (NDC 54092-191-12) |
|---|---|
| Company | Takeda Pharmaceuticals USA Inc. |
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.
-
February 5, 2024 · Class II · Ongoing · D-0350-2024
Failed Dissolution Specifications: Out of specification for dissolution.
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ — SUN PHARMACEUTICAL INDUSTRIES INC
-
January 18, 2024 · Class II · Completed · D-0268-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industri — SUN PHARMACEUTICAL INDUSTRIES INC
-
October 28, 2020 · Class II · Terminated · D-0069-2021
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, ND — Teva Pharmaceuticals USA
-
February 20, 2020 · Class II · Terminated · D-0862-2020
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 059 — Teva Pharmaceuticals USA
-
December 2, 2016 · Class III · Terminated · D-0432-2017
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81 — Shire PLC
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Rowasa, Viatris Specialty LLC, effective August 3, 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 →