Fluoxetine: 6 recalls on record

Recalled by 1 agency: FDA (6).

First recall on record: May 7, 2014. Most recent: June 11, 2025.

Risk classification: Class II: 6

Most recent recalls

DateAgencyProduct
June 11, 2025FDAFluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARM…D-0455-2025
June 11, 2025FDAFluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT…D-0456-2025
May 6, 2015FDAFluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and …D-0971-2015
May 7, 2014FDAFluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Ben…D-1279-2014
May 7, 2014FDAFluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 5…D-1280-2014
May 7, 2014FDAFluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pl…D-1281-2014

Questions about this brand

How many recalls does Fluoxetine have?
Recalert has 6 U.S. recalls on record for Fluoxetine, published between May 7, 2014 and June 11, 2025.
What was the most recent Fluoxetine recall?
FDA recall D-0455-2025, published June 11, 2025: Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13…
Which agencies have recalled Fluoxetine products?
Fluoxetine products appear in recalls from: FDA (6).

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