Indomethacin Capsules USP — Class III drug recall D-0606-2018
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2018-04-04, distributed nationwide. Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsu
| Recall number | D-0606-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2018-03-19 |
| Classified | 2018-03-26 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2019-12-16 |
| Distributed | Nationwide (US) |
| Quantity | 109,080 bottles |
| Reason classes | labeling |
| NDC | 68462-0302, 68462-0302-01, 68462-0302-05, 68462-0406, 68462-0406-01, 68462-0406-10 |
| Lot numbers | 07/19, 08/19, 10/19, 11/19, 19172776, 19172794, 19173111, 19173186, 19173188, 19173189, 19173852, 19173878, 19173893, 19174318, 19174341 |
Product
Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01.
Reason for recall
Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0606-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.