FDA Drug Recalls

Recalls / Active ingredient / Fluoxetine Hydrochloride

Fluoxetine Hydrochloride

7 FDA drug recalls involving the active ingredient “Fluoxetine Hydrochloride.

DateClassProductFirm
2025-05-27Class IIFluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., IndraTorrent Pharma Inc.
2025-05-27Class IIFluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD.,Torrent Pharma Inc.
2015-04-13Class IIFluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical ComTeva Pharmaceuticals USA
2015-04-13Class IIFluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottlTeva Pharmaceuticals USA
2014-02-14Class IIFluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Legacy Pharmaceutical Packaging
2014-02-12Class IIFluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDCTeva Pharmaceuticals USA
2014-02-12Class IIFluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow PharmaceutTeva Pharmaceuticals USA