Indomethacin Extended-Release Capsules Recalled Due to Failed Dissolution Specifications
Glenmark Pharmaceuticals recalls 2,404 bottles of Indomethacin Extended-Release Capsules nationwide due to failed dissolution specifications that could affect medication effectiveness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, hospitalizations, or adverse health outcomes. The hazard—failed dissolution specifications affecting drug effectiveness—is a pharmaceutical quality issue without documented patient harm, consistent with precautionary recalls.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling 2,404 bottles of Indomethacin Extended-Release Capsules, USP, 75 mg, distributed nationwide. The affected product includes 60-count bottles (NDC 68462-325-60) and 90-count bottles (NDC 68462-325-90) with Lot 17240105 and expiration date 12/31/2025.
The recall was initiated due to failed dissolution specifications. Dissolution test results for the affected lot were found to be below specification, which could affect the drug's therapeutic effectiveness.
Patients currently taking affected Indomethacin Extended-Release Capsules should consult their healthcare provider or pharmacist. Do not stop taking the medication without medical guidance. Contact Glenmark Pharmaceuticals or the FDA for information about whether your specific medication is affected.
The recalled product
- Product
- INDOMETHACIN (INDOMETHACIN)
- Brand
- INDOMETHACIN
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- Affected units
- 2,404
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: 17240105
- Exp 12/31/2025
UPCs (1)
- 0368462325605
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · INDOMETHACIN
- ModerateIndomethacin Extended-Release Capsules recalled for cGMP deviations
FDA (Drugs) · 2025-06-11
- ModerateIndomethacin Extended-Release Capsules Recalled for cGMP Deviations
FDA (Drugs) · 2025-05-28
- ModerateGlenmark Pharmaceuticals Recalls Indomethacin Capsules for Manufacturing Deviations
FDA (Drugs) · 2025-04-16
- HighPrescription Drug Indomethacin Recalled Due to Label Mix-Up
FDA (Drugs) · 2023-12-06
- ModerateHetero Labs Recalls Indomethacin Capsules Due to Deformed or Clumped Units
FDA (Drugs) · 2018-08-08
Same manufacturer · Glenmark Pharmaceuticals Inc., USA
See all →- ModerateAzelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
FDA (Drugs) · 2026-08-05
- ModerateAlyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
- ModerateOndansetron tablets recalled because blister packs are not fully sealed
FDA (Drugs) · 2026-01-07
- CriticalFrozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10
Same hazard · failed dissolution
See all →- ModerateNovartis Recalls Diovan Valsartan Tablets Due to Failed Dissolution Specifications
FDA (Drugs) · 2026-08-19
- LowSupernus Recalls Trokendi XR Capsules for Failed Dissolution Specifications
FDA (Drugs) · 2026-07-29
- HighAscend amlodipine and olmesartan tablets failed dissolution specifications
FDA (Drugs) · 2026-06-10
- HighLannett niacin extended-release tablets failed dissolution specifications during stability
FDA (Drugs) · 2026-06-10
- HighMajor Pharmaceuticals memantine extended-release capsules fail dissolution specifications
FDA (Drugs) · 2026-04-22