FDA Drug recall D-0606-2018
Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, In…
- FDA Drug
- Class III
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class III recall of Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, In… by Glenmark Pharmaceuticals Usa, citing 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 o….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0606-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-03-19 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
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.
Identifiers
| ndc | 68462-406-01 |
|---|---|
| ndc | 68462-406-10 |
| ndc | 68462-302-01 |
| ndc | 68462-302-05 |
| code_info | Lot #: 19172776, 19172794, Exp 07/19; 19173111, 19173186, 19173188, 19173189, Exp 08/19; 19173852, 19173878, 19173893, Exp 10/19; 19174318, 19174341, Exp 11/19. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0606-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.