Prescription Drug Indomethacin Recalled Due to Label Mix-Up
Glenmark Pharmaceuticals is recalling 37,200 bottles of Indomethacin 25mg capsules distributed nationwide because the bottles may be labeled as Naproxen instead. This labeling error could cause medication confusion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a serious labeling error where Indomethacin bottles may be labeled as Naproxen. The mislabeling creates a high risk of medication error, which could result in serious harm. No illnesses or injuries are reported in the source material.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling 37,200 bottles of Indomethacin 25mg Capsules, USP distributed nationwide. The affected product has NDC 68462-406-01 and was manufactured by Glenmark Pharmaceuticals Ltd. in Colvale-Bardez, Goa 403513, India.
The recall was initiated because the bottles may be labeled as Naproxen instead of Indomethacin. This labeling error creates a risk that consumers could inadvertently take the wrong medication. The affected lots are: Lot# 19231903 (Exp 4/2025), Lot# 19231858 (Exp 4/2025), Lot# 19231881 (Exp 4/2025), Lot# 19233484 (Exp 8/2025), and Lot# 19233490 (Exp 8/2025).
The product was distributed nationwide to pharmacies and consumers. Consumers who have this product should verify that the actual medication matches the label before taking it.
If you have a bottle of this product matching the lot numbers above, contact your pharmacy or healthcare provider before using it. Do not take the medication if you cannot verify that the contents match the label. For more information, contact Glenmark Pharmaceuticals Inc., USA.
The recalled product
- Product
- INDOMETHACIN (INDOMETHACIN)
- Brand
- INDOMETHACIN
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- Affected units
- 37,200
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 (6)
- Lot# 19231903
- Exp 4/2025 Lot# 19231858
- Exp 4/2025 Lot# 19231881
- Exp 4/2025 Lot# 19233484
- Exp 8/2025 Lot# 19233490
- Exp 8/2025
UPCs (2)
- 0368462406014
- 0368462302019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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