Mesalamine Capsule, Extended Release shortage
Mesalamine Capsule, Extended Release is currently listed in shortage by the FDA. The FDA lists 3 affected products. This page was last refreshed from FDA data on Sep 21, 2026.
Mylan is stopping its manufacture of mesalamine extended-release capsules, and no supply from the reporting makers is currently available. Other makers not reporting a shortage — including Teva and Upsher-Smith — still list mesalamine extended-release and delayed-release capsules in their product lines.
Don’t stop or change your therapy on your own — talk with your prescriber about the plan that fits you, and ask your pharmacist what’s actually available (see options).
Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →What’s in shortage — at a glance
These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Mesalamine Capsule, Extended Release. Other makers that haven’t reported a problem are shown in the green card below.
Shortage timeline
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Sep 16, 2026Currently in shortage3 of 3 products affected.
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Sep 16, 2026More presentations reported2 more products added to the shortage.
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Aug 25, 2026First reported to the FDA1 product first listed.
Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.
What exactly is on backorder — by manufacturer
Manufacturer: Mylan Pharmaceuticals Inc., a Viatris Company 📞 800-796-9526 1 NDC click to expand
| Status | NDC / product | Strength | Availability | Related information | Reason |
|---|---|---|---|---|---|
| To Be Discontinued | Mesalamine, Capsule, Extended Release, .375 g (NDC 0378-1375-78) | — | — | Discontinuation of the manufacture of the drug | — |
Manufacturer: Takeda Pharmaceuticals USA Inc. 📞 877 825 3327 2 NDCS click to expand
| Status | NDC / product | Strength | Availability | Related information | Reason |
|---|---|---|---|---|---|
| To Be Discontinued | Pentasa, Capsule, Extended Release, 500 mg (NDC 54092-191-12) | — | — | Product is anticipated to be available until December 31, 2027 | — |
| To Be Discontinued | Pentasa, Capsule, Extended Release, 250 mg (NDC 54092-189-81) | — | — | Product is anticipated to be available until December 31, 2027 | — |
These rows are manufacturer reports to the FDA for Mesalamine Capsule, Extended Release — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Mesalamine Capsule, Extended Release? options further down this page.
Why is Mesalamine Capsule, Extended Release in shortage?
There are actually two separate situations wrapped into this one shortage listing, so let me break them down simply. Mylan Pharmaceuticals (a Viatris company) has permanently stopped making their 0.375 g extended-release mesalamine capsules — they didn't share a specific public reason for that decision, just that manufacturing of that product is being discontinued. Takeda Pharmaceuticals has a different story for their brand-name version, Pentasa: both the 250 mg and 500 mg extended-release capsules are still being made right now, but Takeda has reported to the FDA that those products are expected to be available only until December 31, 2027, after which they anticipate supply will end.
Based on the manufacturer-reported reason(s) and notes on file with the FDA for Mesalamine Capsule, Extended Release, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.
What should I do if I take Mesalamine Capsule, Extended Release?
Mesalamine Extended Release Capsules are currently on the FDA drug-shortage list, and the record shows this product is marked "To Be Discontinued." I want to walk you through what that means so you can plan ahead calmly.
Right now, none of the three strengths on this record — .375 g, 250 mg, and 500 mg — have an available source reported from the two manufacturers who filed. The 250 mg and 500 mg strengths (Pentasa, from Takeda) are anticipated to remain available until December 31, 2027, while the .375 g strength (from Mylan) is listed as a discontinuation of manufacture. Because this involves planned discontinuation, the supply issue for these specific products may be lasting rather than temporary.
Please keep in mind this is national, manufacturer-reported data and may not match your local pharmacy's actual stock. Here is what I suggest, in order:
- Do not stop, skip, or change your dose on your own.
- Ask your pharmacy to check wholesalers and other makers for your strength — supply can vary locally.
- The same medicine (mesalamine extended-release capsules) is listed from other makers, including Teva, Upsher-Smith, Aurobindo, Alembic, Sun, Ascend, and Salix (Apriso); your pharmacy may be able to source one, though it may not be in local stock.
- If your exact strength cannot be found, ask your prescriber or pharmacist about options.
Manufacturer contact numbers are listed on this page for reference; pharmacies usually handle those calls.
- Don’t stop or change the medication on your own — talk to your prescriber first.
- If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
- Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
- Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.
Where else can I get Mesalamine Capsule, Extended Release?
FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Mesalamine Capsule, Extended Release is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.
Same medicine, other manufacturers (not reported short)
Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:
| Product | Strength | Form / route | Manufacturer | NDC |
|---|---|---|---|---|
| Mesalamine | MESALAMINE 400 mg/1 | Capsule, Delayed Release · Oral | Teva Pharmaceuticals USA, Inc. | 00093-5907-86 |
| Mesalamine | MESALAMINE 375 mg/1 | Capsule, Extended Release · Oral | Teva Pharmaceuticals USA, Inc. | 00093-9224-89 |
| Mesalamine | MESALAMINE .375 g/1 | Capsule, Extended Release · Oral | Upsher-Smith Laboratories, LLC | 00832-6056-12 |
| Mesalamine | MESALAMINE .375 g/1 | Capsule, Extended Release · Oral | AvPAK | 50268-0577-15 |
| Mesalamine | MESALAMINE .375 g/1 | Capsule, Extended Release · Oral | Golden State Medical Supply, Inc. | 51407-0976-12 |
| Mesalamine | MESALAMINE .375 g/1 | Capsule, Extended Release · Oral | Aurobindo Pharma Limited | 59651-0397-08 |
| Mesalamine | MESALAMINE 400 mg/1 | Capsule, Delayed Release · Oral | American Health Packaging | 60687-0556-32 |
| Mesalamine | MESALAMINE .375 g/1 | Capsule, Extended Release · Oral | American Health Packaging | 60687-0650-32 |
| Mesalamine | MESALAMINE .375 g/1 | Capsule, Extended Release · Oral | Alembic Pharmaceuticals Inc. | 62332-0724-35 |
| Mesalamine | MESALAMINE 500 mg/1 | Capsule, Extended Release · Oral | Sun Pharmaceutical Industries Inc. | 63304-0089-13 |
| Apriso | MESALAMINE 375 mg/1 | Capsule, Extended Release · Oral | Salix Pharmaceuticals, Inc. | 65649-0103-01 |
| Mesalamine | MESALAMINE .375 g/1 | Capsule, Extended Release · Oral | Ascend Laboratories, LLC | 67877-0717-05 |
Alternative dosage forms of Mesalamine
A different form of the same drug (for example a solution when capsules are short). A form change is a clinical decision — ask your prescriber:
Therapeutic equivalents & pricing 19 productsclick to expand
Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.
| Product | Manufacturer | Package | NADAC $/unit | AB rating | Availability |
|---|---|---|---|---|---|
| mesalamine 375 mg | Teva | 120 capsules | $0.487 | AB | Availability likely |
| Mesalamine .375 g | Mylan | 120 capsules | $0.487 | AB | Availability likely |
| Mesalamine .375 g | Upsher-Smith | 120 capsules | $0.487 | AB | Availability likely |
| Mesalamine .375 g | AvPAK | 1 capsule | $0.487 | AB | Availability likely |
| Mesalamine .375 g | Aurobindo | 120 capsules | $0.487 | AB | Availability likely |
| Mesalamine .375 g | American | 1 capsule | $0.487 | AB | Availability likely |
| Mesalamine .375 g | Alembic | 120 capsules | $0.487 | AB | Availability likely |
| Mesalamine .375 g | Zydus | 120 capsules | $0.487 | AB | Availability likely |
| mesalamine 375 mg | Oceanside | 120 capsules | $0.727 | AB | FDA listed |
| Pentasa 250 mg | Takeda | 240 capsules | $2.903 | AB | Availability likely |
| Mesalamine 500 mg | Sun | 120 capsules | $3.470 | AB | Availability likely |
| Pentasa 500 mg | Takeda | 120 capsules | $5.826 | AB | Availability likely |
| Mesalamine 375 mg | Camber | 120 capsules | — | AB | FDA listed |
| Mesalamine .375 g | Alembic | 120 capsules | — | AB | FDA listed |
| Mesalamine .375 g | Ingenus | 120 capsules | — | AB | FDA listed |
| Mesalamine .375 g | Golden | 120 capsules | — | AB | FDA listed |
| Apriso 375 mg | Salix | 4 capsules | — | AB | FDA listed |
| Mesalamine .375 g | Ascend | 500 capsules | — | AB | FDA listed |
| Mesalamine .375 g | Zydus | 120 capsules | — | AB | FDA listed |
Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.
Other drugs in the same treatment class
These are different medicines — not other versions of Mesalamine Capsule, Extended Release — that fall in the same broad treatment class (drug tx-chronic inflam. colon dx,5-aminosalicylat) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.
Identity & classification
Where does this data come from?
Other gastroenterology shortages
Mesalamine Capsule, Extended Release shortage FAQs
Is Mesalamine Capsule, Extended Release in shortage?
Which products are affected?
When will Mesalamine Capsule, Extended Release be available again?
Can I still get Mesalamine somewhere?
What should I do if I take Mesalamine Capsule, Extended Release?
Still have a question about the Mesalamine Capsule, Extended Release shortage?
Ask a pharmacist about this shortage →View Mesalamine Capsule, Extended Release on the FDA drug-shortage database →
Where does this data come from?
/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.