LANSOPRAZOLE
Generic: LANSOPRAZOLE
Ajanta Pharma USA Inc.Manufacturer
ORALRoute
LANSOPRAZOLEActive Substance
2016-10-14Original Approval
LANSOPRAZOLE is FDA application ANDA203957, sponsored by AJANTA PHARMA LTD. 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 II2020-12-03
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Failed Dissolution Specifications
Class II2022-03-23
Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories LFailed Dissolution Specifications; during long term stability testing.
Class II2022-03-23
Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-39Failed Dissolution Specifications; during long term stability testing.
Class III2019-03-11
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), RxSubpotent Drug.
Class II2020-12-03
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx onlyFailed Dissolution Specifications
Class II2013-01-30
Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan PharmPresence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may con
Class II2020-10-27
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, ManufactFailed Dissolution Specification
Class II2020-10-27
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, ManufactFailed Dissolution Specification
Top Reported Reactions
1
DIARRHOEA
6,597 reports
2
DYSPNOEA
5,955 reports
3
NAUSEA
5,681 reports
4
OFF LABEL USE
5,318 reports
5
FATIGUE
5,270 reports
6
VOMITING
5,195 reports
7
ACUTE KIDNEY INJURY
4,968 reports
8
MALAISE
4,719 reports
9
HEADACHE
4,708 reports
10
CHRONIC KIDNEY DISEASE
4,675 reports