CLASS II Drug recall · Reported 7 May 2014 · FDA Enforcement Report

Fluoxetine Capsules USP, 20 mg recalled by Teva Pharmaceuticals U

Teva Pharmaceuticals USA is recalling Fluoxetine Capsules USP, 20 mg, distributed nationwide in the US. The recall was initiated on 12 Feb 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15; 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15; b) 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15; c) 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15; 6A211139, 6A211140, 6A211141, Exp 11/15; 6A212087, Exp 12/15; d) 6A209124, Exp 09/15; 6A211144, 6A211148, 6A211149, Exp 11/15

NDC50111-647, 50111-648

Quantity recalled257904 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-1280-2014
FDA event ID: 67563
Recalling firm: Teva Pharmaceuticals USA, Horsham, PA
Brand: Fluoxetine
Manufacturer: Teva Pharmaceuticals USA, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 12 Feb 2014
FDA classified: 28 Apr 2014
Reported: 7 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Antidepressants

Timeline

12 Feb 2014	Recall initiated by company
28 Apr 2014	Classified by FDA	+75 days
7 May 2014	Published in enforcement report	+9 days

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

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot #: a) 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15; 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15; b) 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15; c) 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15; 6A211139, 6A211140, 6A211141, Exp 11/15; 6A212087, Exp 12/15; d) 6A209124, Exp 09/15; 6A211144, 6A211148, 6A211149, Exp 11/15

Where was it sold?

Nationwide and Puerto Rico

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

Other products in this recall event

1 other product · FDA event 67563

Reported	Class	Recall	Company	Reason	Where
7 May 2014	CLASS II	Fluoxetine Capsules USP, 10 mg recalled by Teva Pharmaceuticals UFluoxetine	Teva Pharmaceuticals USA	Other	Nationwide

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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