OMEPRAZOLE MAGNESIUM
Generic: OMEPRAZOLE MAGNESIUM
Gericare PharmaceuticalsManufacturer
ORALRoute
OMEPRAZOLE MAGNESIUMActive Substance
2009-06-05Original Approval
OMEPRAZOLE MAGNESIUM is FDA application ANDA078878, sponsored by DR REDDYS LABS 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 II2025-06-30
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories LiPresence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg t
Class II2013-09-16
Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban PharmaFailed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not mee
Top Reported Reactions
1
FATIGUE
20,843 reports
2
NAUSEA
20,808 reports
3
DIARRHOEA
20,636 reports
4
DYSPNOEA
17,106 reports
5
DRUG INEFFECTIVE
16,566 reports
6
HEADACHE
15,390 reports
7
PAIN
14,434 reports
8
CHRONIC KIDNEY DISEASE
14,158 reports
9
VOMITING
13,868 reports
10
DIZZINESS
13,771 reports