CLASS III Drug recall · Reported 4 Apr 2018 · FDA Enforcement Report
Indomethacin Capsules USP, 50 mg recalled by Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Inc., USA is recalling Indomethacin Capsules USP, 50 mg, distributed nationwide in the US. The recall was initiated on 19 Mar 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0606-2018
- FDA event ID
- 79570
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Brand
- Indomethacin
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Mar 2018
- FDA classified
- 26 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
Timeline
| 19 Mar 2018 | Recall initiated by company | |
| 26 Mar 2018 | Classified by FDA | +7 days |
| 4 Apr 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the United States.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 19172776, 19172794, Exp 07/19; 19173111, 19173186, 19173188, 19173189, Exp 08/19; 19173852, 19173878, 19173893, Exp 10/19; 19174318, 19174341, Exp 11/19.
Where was it sold?
Nationwide in the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Glenmark Pharmaceuticals Inc., USA
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
Other Indomethacin recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Indomethacin Extended-Release Capsules, USP, 75 mg recalledIndomethacin | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Indomethacin Extended-Release Capsules USP, 75 mg recalled by KVK TechIndomethacin | KVK Tech | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Indomethacin Extended-Release Capsules, 75mg recalledIndomethacin | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Indomethacin Extended-Release Capsules, USP, 75 mg recalledIndomethacin | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Indomethacin 25mg Capsules recalled by Glenmark PharmaceuticalsIndomethacin | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |