CLASS III Drug recall · Reported 21 Feb 2018 · FDA Enforcement Report
Fluoxetine Tablets USP, 10 mg recalled by Teva Pharmaceuticals U
Teva Pharmaceuticals USA is recalling Fluoxetine Tablets USP, 10 mg, distributed nationwide in the US. The recall was initiated on 5 Feb 2018 and the FDA has classified it as Class III.
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-0578-2018
- FDA event ID
- 79118
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Feb 2018
- FDA classified
- 5 Mar 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 5 Feb 2018 | Recall initiated by company | |
| 21 Feb 2018 | Published in enforcement report | +16 days |
| 5 Mar 2018 | Classified by FDA | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
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 Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56
Where it was distributed
Distributed throughout the United States
Questions about this recall
Why was it recalled?
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Which lots are affected?
All lots within expiry.
Where was it sold?
Distributed throughout the United States
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 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 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 |
| Drug | CLASS III | Fluoxetine Capsules USP, 20 mg recalled by Sandoz Incorporated | Sandoz | Other | AZ |