Mesalamine Capsule, Extended Release shortage
To Be Discontinued 3 presentations · 2 manufacturers · first FDA posting 2026-08-25 · last update 2026-09-16
Manufacturers: Mylan Pharmaceuticals Inc., a Viatris Company, Takeda Pharmaceuticals USA Inc.
Stated reasons (per FDA): Not stated
Presentations
| Presentation | Manufacturer | Status | Reason | Notes (FDA) | Dates |
|---|---|---|---|---|---|
| Mesalamine, Capsule, Extended Release, .375 g (NDC 0378-1375-78) | Mylan Pharmaceuticals Inc., a Viatris Company | To Be Discontinued | — | Discontinuation of the manufacture of the drug | Posted 08/25/2026 Updated 08/25/2026 Discontinued 08/25/2026 |
| Pentasa, Capsule, Extended Release, 250 mg (NDC 54092-189-81) | Takeda Pharmaceuticals USA Inc. | To Be Discontinued | — | Product is anticipated to be available until December 31, 2027 | Posted 09/16/2026 Updated 09/16/2026 Discontinued 09/16/2026 |
| Pentasa, Capsule, Extended Release, 500 mg (NDC 54092-191-12) | Takeda Pharmaceuticals USA Inc. | To Be Discontinued | — | Product is anticipated to be available until December 31, 2027 | Posted 09/16/2026 Updated 09/16/2026 Discontinued 09/16/2026 |
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