CLASS II Drug recall · Reported 6 May 2015 · FDA Enforcement Report

Fluoxetine Capsules USP, 10 mg recalled by Teva Pharmaceuticals U

Teva Pharmaceuticals USA is recalling Fluoxetine Capsules USP, 10 mg, distributed nationwide in the US. The recall was initiated on 13 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 6A207012, Exp 7/2015.

NDC50111-647, 50111-648

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-0970-2015
FDA event ID: 70976
Recalling firm: Teva Pharmaceuticals USA, Horsham, PA
Brand: Fluoxetine
Manufacturer: Teva Pharmaceuticals USA, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 13 Apr 2015
FDA classified: 27 Apr 2015
Reported: 6 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Antidepressants

Timeline

13 Apr 2015	Recall initiated by company
27 Apr 2015	Classified by FDA	+14 days
6 May 2015	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: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.

Which lots are affected?

Lot #: 6A207012, Exp 7/2015.

Where was it sold?

Nationwide

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 70976

This product is part of a recall event; the main page for the event is Fluoxetine Capsules USP, 20 mg recalled by Teva Pharmaceuticals U.

Reported	Class	Recall	Company	Reason	Where
6 May 2015	CLASS II	Fluoxetine Capsules USP, 20 mg recalled by Teva Pharmaceuticals UFluoxetine	Teva Pharmaceuticals USA	Potency & Assay	Nationwide

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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, 20 mg recalled by Teva Pharmaceuticals UFluoxetine	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
17 Dec 2014Drug	CLASS III	Fluoxetine Capsules USP, 20 mg recalled by Sandoz Incorporated	Sandoz	Other	AZ