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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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