CLASS III Drug recall · Reported 17 Dec 2014 · FDA Enforcement Report

Fluoxetine Capsules USP, 20 mg recalled by Sandoz Incorporated

Sandoz is recalling Fluoxetine Capsules USP, 20 mg, distributed in Arizona. The recall was initiated on 5 Dec 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot ET5122, Exp. 10/17

Quantity recalled1,008 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0291-2015
FDA event ID: 69942
Recalling firm: Sandoz, Broomfield, CO
Classification: Class III
Status: Terminated
Recall initiated: 5 Dec 2014
FDA classified: 9 Dec 2014
Reported: 17 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Antidepressants

Timeline

5 Dec 2014	Recall initiated by company
9 Dec 2014	Classified by FDA	+4 days
17 Dec 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.

Product as listed by the FDA

Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01

Where it was distributed

Arizona

Questions about this recall

Why was it recalled?

Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.

Which lots are affected?

Lot ET5122, Exp. 10/17

Where was it sold?

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Sandoz

All 59

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Drug	CLASS III	Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin	Sandoz	Other	Nationwide
24 Sep 2025Drug	CLASS II	Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide	Sandoz	Manufacturing (CGMP) Deviations	Nationwide
17 Sep 2025Drug	CLASS II	Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone	Sandoz	Temperature Abuse	CA
9 Jul 2025Drug	CLASS I	Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium	Sandoz	Labeling Errors	Nationwide
9 Jul 2025Drug	CLASS I	Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin	Sandoz	Packaging Defects	Nationwide

Other Fluoxetine recalls

All 10

Reported	Class	Recall	Company	Reason	Where
11 Jun 2025Drug	CLASS II	Fluoxetine Tablets, USP, 20 mg recalled by Torrent PharmaFluoxetine	Torrent Pharma	Nitrosamine Impurity	Nationwide
11 Jun 2025Drug	CLASS II	Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalledFluoxetine	Torrent Pharma	Nitrosamine Impurity	Nationwide
21 Feb 2018Drug	CLASS III	Fluoxetine Tablets USP, 10 mg recalled by Teva Pharmaceuticals U	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
6 May 2015Drug	CLASS II	Fluoxetine Capsules USP, 10 mg recalled by Teva Pharmaceuticals UFluoxetine	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
6 May 2015Drug	CLASS II	Fluoxetine Capsules USP, 20 mg recalled by Teva Pharmaceuticals UFluoxetine	Teva Pharmaceuticals USA	Potency & Assay	Nationwide