INDOMETHACIN

Generic: INDOMETHACIN

NorthStar RxLLCManufacturer

RECTALRoute

INDOMETHACINActive Substance

2025-07-03Original Approval

INDOMETHACIN is FDA application ANDA216905, sponsored by ANNORA PHARMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2025-05-15

Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed

cGMP deviations

Class II2024-07-31

Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count b

Failed Dissolution Specifications: below specification results

Class III2018-03-19

Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bar

Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or

Class II2025-05-09

Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 1894

cGMP deviations

Class II2018-07-18

Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscatawa

Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or

Class II2023-11-07

Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Barde

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Class II2025-03-13

Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pitha

CGMP Deviations

Top Reported Reactions

1

DRUG INEFFECTIVE

1,294 reports

2

FATIGUE

1,054 reports

3

HEADACHE

966 reports

4

ARTHRALGIA

951 reports

5

OFF LABEL USE

944 reports

6

PAIN

847 reports

7

DIARRHOEA

829 reports

8

NAUSEA

829 reports

9

DIZZINESS

801 reports

10

VOMITING

688 reports