CLASS II Drug recall · Reported 7 May 2014 · 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 12 Feb 2014 and the FDA has classified it as Class II.
Check your package
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-1281-2014
- 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
- Other Reasons
- 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.
Product as listed by the FDA
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.
Where it was distributed
Nationwide and 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 #: 6A211158, 6A211159, 6A211163, 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 67563This 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 |
|---|---|---|---|---|---|
| CLASS II | Fluoxetine Capsules USP, 20 mg recalled by Teva Pharmaceuticals UFluoxetine | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |
More recalls from Teva Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Fluoxetine recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluoxetine Tablets, USP, 20 mg recalled by Torrent PharmaFluoxetine | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalledFluoxetine | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Fluoxetine Tablets USP, 10 mg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluoxetine Capsules USP, 10 mg recalled by Teva Pharmaceuticals UFluoxetine | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluoxetine Capsules USP, 20 mg recalled by Teva Pharmaceuticals UFluoxetine | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |