SERTRALINE HYDROCHLORIDE
Generic: SERTRALINE HYDROCHLORIDE
ANI PharmaceuticalsManufacturer
ORALRoute
SERTRALINE HYDROCHLORIDEActive Substance
2026-01-20Original Approval
SERTRALINE HYDROCHLORIDE is FDA application ANDA219714, sponsored by NOVITIUM 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 II2023-12-11
Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured forCGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Class II2025-11-05
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc.,Defective container - seal not adhering to bottles
Top Reported Reactions
1
NAUSEA
1,926 reports
2
HEADACHE
1,882 reports
3
FATIGUE
1,641 reports
4
DRUG INEFFECTIVE
1,602 reports
5
DEPRESSION
1,502 reports
6
DIARRHOEA
1,367 reports
7
DYSPNOEA
1,353 reports
8
DRUG INTERACTION
1,342 reports
9
DIZZINESS
1,324 reports
10
OFF LABEL USE
1,318 reports