FLUOXETINE HYDROCHLORIDE

Generic: FLUOXETINE HYDROCHLORIDE

Dr.Reddy's Laboratories LimitedManufacturer
ORALRoute
FLUOXETINE HYDROCHLORIDEActive Substance
2010-03-22Original Approval

FLUOXETINE HYDROCHLORIDE is FDA application ANDA078572, 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 II2015-04-13
Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50

Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in

Class II2025-05-27
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-38

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

Class II2014-02-12
Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648

Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

Class II2014-02-12
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Compa

Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

Class II2014-02-14
Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactur

Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules

Class II2015-04-13
Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A.,

Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in

Class II2025-05-27
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

Top Reported Reactions

1
DRUG INEFFECTIVE
4,764 reports
2
DRUG INTERACTION
4,359 reports
3
NAUSEA
4,355 reports
4
FATIGUE
4,344 reports
5
TOXICITY TO VARIOUS AGENTS
4,168 reports
6
HEADACHE
3,893 reports
7
COMPLETED SUICIDE
3,526 reports
8
OFF LABEL USE
3,426 reports
9
DIZZINESS
3,256 reports
10
DIARRHOEA
3,249 reports